BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32G 4MM 5B XTW 7CT CARTON

    MDR report key: 10053585 · Received May 13, 2020

    Report

    Report Number
    9616656-2020-00422
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    May 1, 2020
    Report Date
    May 4, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205400
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7052840, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2018-04-11, MEDICAL DEVICE LOT #: 7012659, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2017-09-13. THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) USA HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY: OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST. RELATED COMPLAINT FOR INCORRECT/MISSING LABEL INFORMATION ON LOT # 7052840 & LOT # 7012659. NO SAMPLES 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 CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO EXPIRATION DATE ON 5 PACKS OF PEN NEEDLES 32G 4MM 5B XTW 7CT CARTON IN LOT# 7052840, AND AN UNSPECIFIED NUMBER OF PACKS FROM LOT# 7012659, BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOUSE OF CONSUMER CALLED TO CONFIRM IF SAMPLE PACKS OF BD PEN NEEDLES ARE STILL GOOD. STATED THERE IS NO EXPIRATION DATE ON ANY OF THE PACKS, HOWEVER CONFIRMED A COPYRIGHT DATE OF 2016 ON ALL SAMPLE PACKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517795 PEN NEEDLE 32G 4MM 5B XTW 7CT CARTON HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320540 SEE SECTION H.10. 00382903205400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other