BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 5MM 100BX 1200 USA

    MDR report key: 10969831 · Received December 8, 2020

    Report

    Report Number
    9616656-2020-01237
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 12, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201198
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 31GA 5MM 100BX 1200 USA WAS MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:20119 BATCH NO: 6061838. IT WAS REPORTED WAS UNABLE TO LOCATE THE EXPIRATION DATE. WIDOW CALLED AND EXPLAINED SHE HAS SYRINGES HER LATE HUSBAND NEVER GOT A CHANCE TO USE AND WANTED TO KNOW WHERE THE EXPIRATION DATE IS ON THE BOX. WIFE IS GOING TO DONATE THE UNOPENED BOX TO A VETERINARIAN.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6). 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 PEN NDL 31GA 5MM 100BX 1200 USA WAS MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:20119, BATCH NO: 6061838. IT WAS REPORTED WAS UNABLE TO LOCATE THE EXPIRATION DATE. WIDOW CALLED AND EXPLAINED SHE HAS SYRINGES HER LATE HUSBAND NEVER GOT A CHANCE TO USE AND WANTED TO KNOW WHERE THE EXPIRATION DATE IS ON THE BOX. WIFE IS GOING TO DONATE THE UNOPENED BOX TO A VETERINARIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429005 PEN NDL 31GA 5MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320119 6061838 00382903201198

    Patients

    Seq Age Sex Outcome Treatment
    1