BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 11223466 · Received January 25, 2021

    Report

    Report Number
    9616656-2021-00064
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    January 4, 2021
    Report Date
    March 3, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM 100BX 1200 USA WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE CLOGGED DURING INJECTION. VERBATIM: CONSUMER REPORTED FINDING PEN NEEDLES CLOG DURING INJECTION SOMETIMES 2-3 PEN NEEDLES IN A ROW. INFORMED CONSUMER PROPER PLACEMENT OF THE NON PATIENT END. AND TO PRIME THE PEN NEEDLE .CONSUMER DOES NOT REUSE. FINDING ISSUES WITH JUST THESE TWO BOXES. NOT PRIOR BOXES LOT #: 0063209, LOT # 0142932, CATALOG#: 320122, DATE OF EVENT: UNKNOWN SAMPLES STATUS DISCARD".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0063209. MEDICAL DEVICE EXPIRATION DATE: 2025-02-28. DEVICE MANUFACTURE DATE: 2020-03-03. MEDICAL DEVICE LOT #: 0142932. MEDICAL DEVICE EXPIRATION DATE: 2025-05-31. DEVICE MANUFACTURE DATE: 2020-08-24. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM 100BX 1200 USA WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE CLOGGED DURING INJECTION. VERBATIM: CONSUMER REPORTED FINDING PEN NEEDLES CLOG DURING INJECTION SOMETIMES 2-3 PEN NEEDLES IN A ROW. INFORMED CONSUMER PROPER PLACEMENT OF THE NON PATIENT END. AND TO PRIME THE PEN NEEDLE .CONSUMER DOES NOT REUSE. FINDING ISSUES WITH JUST THESE TWO BOXES. NOT PRIOR BOXES. LOT #:0063209, LOT # 0142932, CATALOG#: 320122. DATE OF EVENT: UNKNOWN, SAMPLES STATUS DISCARD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119361 PEN NDL 32G 4MM 100BX 1200 USA PEN NDL 32G 4MM 100BX 1200 USA FMI BECTON DICKINSON AND CO. 2865 SEE H.10. 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1