BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ PEN NEEDLE

    MDR report key: 15480730 · Received September 24, 2022

    Report

    Report Number
    9616656-2022-01037
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    August 31, 2022
    Report Date
    September 29, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903204991
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?YES,. D10: RETURNED TO MANUFACTURER ON: 07-OCT-2022 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (2) OPEN SHELF CARTONS FOR 31GX8MM BD PEN NEEDLES FROM LOT# 1342180. THE CUSTOMER REPORTED THAT THE PZN FOR 5MM CANNULAS STICKS TO PACKS WITH 8MM CANNULAS. THE RETURNED SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT A PZN LABEL MARKED ¿09239168¿ WAS ADHERED TO THE SIDE OF THE SHELF CARTON DISPLAYING THE LOT INFORMATION. AS PER MANUFACTURING THIS LABEL WAS APPLIED OUTSIDE OF [MANUFACTURING - DUN LAOGHAIRE] CONTROL. THIS TYPE OF LABEL IS NOT USED DURING THE MANUFACTURING PROCESS. THE ALLEGED DEFECT COULD NOT BE TRACED TO MANUFACTURING. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE CANNOT BE TRACED TO MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 5MM BD MICRO-FINE¿+ PEN NEEDLE LABEL STUCK THE PACK OF 8MM CANNULAS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "THE PZN OF THE 5MM CANNULAS STICKS TO PACKS WITH 8MM CANNULAS".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 5MM BD MICRO-FINE¿+ PEN NEEDLE LABEL STUCK THE PACK OF 8MM CANNULAS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "THE PZN OF THE 5MM CANNULAS STICKS TO PACKS WITH 8MM CANNULAS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2392014 BD MICRO-FINE¿+ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1342180 00382903204991

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown