BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    MDR report key: 11429570 · Received March 7, 2021

    Report

    Report Number
    9616656-2021-00230
    Event Type
    Malfunction
    Date Received
    March 7, 2021
    Date of Event
    February 9, 2021
    Report Date
    May 4, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 PEN NDL 32G 4MM HP 100 BOX 1200 US WERE DIFFICULT TO OPERATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT PEN NEEDLE WILL NOT ATTACH TO INSULIN PEN. VERBATIM: FROM PHONE CALL ON 2021-02-10 16:57:00: STATED, LAST NIGHT, 4 PEN NEEDLES DID NOT ATTACH, (2021-02-09) STATED, CANNOT ATTACH PEN NEEDLES TO INSULIN PEN STATED, 10 PEN NEEDLES AFFECTED IN TOTAL LOT: 0203720 CATALOG: 320550 DATE OF EVENT: (B)(6) 2021 SAMPLES: YES CL BD CONSUMER LEFT VOICEMAIL COMPLAINT STATED, EVERY 2 OUT 3 PEN NEEDLES WILL NOT ATTACH TO INSULIN PEN. CL".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 PEN NDL 32G 4MM HP 100 BOX 1200 US WERE DIFFICULT TO OPERATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT PEN NEEDLE WILL NOT ATTACH TO INSULIN PEN. VERBATIM: FROM PHONE CALL ON (B)(6) 2021 16:57:00: STATED, LAST NIGHT, 4 PEN NEEDLES DID NOT ATTACH, ((B)(6) 2021) STATED, CANNOT ATTACH PEN NEEDLES TO INSULIN PEN STATED, 10 PEN NEEDLES AFFECTED IN TOTAL LOT: 0203720. CATALOG: 320550. DATE OF EVENT: (B)(6) 2021. SAMPLES: YES CL. BD CONSUMER LEFT VOICEMAIL COMPLAINT STATED, EVERY 2 OUT 3 PEN NEEDLES WILL NOT ATTACH TO INSULIN PEN. CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324295 PEN NDL 32G 4MM HP 100 BOX 1200 US HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0203720 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1