WARNING LETTER
Becton, Dickinson, and Company/CareFusion was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals:
CMS# 691601
Becton, Dickinson, and Company/CareFusion 303, Inc.
1 Becton Drive Franklin Lakes, NJ 07417United States
Dates: May 6, 2024 through May 22, 2024
Inspection Issue(s):
Report states, “your firm manufactures Pyxis Medication Management System medical devices including, but not limited to, Pyxis MedStation ES, Pyxis ES Anesthesia, and Pyxis MedBank (hereafter also referred to as Pyxis) Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.”
- Failure to establish and implement procedures for corrective and preventive actions as required by 21 CFR 820.100(a). Failure to establish and implement procedures for corrective and preventive actions as required by 21 CFR 820.100(a).
- Our inspection revealed that your firm’s Pyxis devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting. ailure to submit a report to the FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).
- The information included for Complaint# 02840390 describes an adverse event occurring as the result of malfunction of your firm’s Pyxis MedStation ES System (i.e. unexpected reboot) while in use. The MDR#2016493-2020-00001 received by FDA describes an event where the patient sustained a serious injury resulting from your firm’s same device malfunction.
- Our inspection also revealed that your firm’s Pyxis devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
For more information, see the link below:
Becton, Dickinson, and Company/CareFusion 303, Inc. – 691601 – 11/22/2024 | FDA
