BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PN 31G 5MM 5B XTW

    MDR report key: 10428034 · Received August 19, 2020

    Report

    Report Number
    9616656-2020-00828
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    July 23, 2020
    Report Date
    September 3, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 9616656-2020-00828 WAS SENT IN ERROR. FURTHER REVIEW OF PHOTOS RECEIVED DETERMINE THE MALFUNCTION TO BE DAMAGED OR OPEN PACKAGE (SHELF CARTON OR CASE) / SEAL WHERE STERILITY IS NOT COMPROMISED WHICH IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE THE SHELF CONTAINER PACKAGING WAS DISCOVERED TO BE DAMAGED, THUS AFFECTING STERILITY WITH A BD PN 31G 5MM 5B XTW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DAMAGED CARTON.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE FOLLOWING IS FOR A LOT THOUGHT TO POSSIBLY BE INVOLVED: MEDICAL DEVICE LOT #: 0112348, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-04-21. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE THE SHELF CONTAINER PACKAGING WAS DISCOVERED TO BE DAMAGED, THUS AFFECTING STERILITY WITH A BD PN 31 G 5 MM 5 B XTW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DAMAGED CARTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889652 BD PN 31G 5MM 5B XTW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other