BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 29GA 12.7MM 10BAG 500 WAL

    MDR report key: 11510052 · Received March 17, 2021

    Report

    Report Number
    1920898-2021-00311
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 19, 2021
    Report Date
    April 14, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311663
    PMA / PMN Number
    K941657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 29GA 12.7MM 10BAG 500 WAL WAS MISSING THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328510 BATCH NO: 5180853. IT WAS REPORTED NO EXPIRATION DATE ON A BOX OF RELION SYRINGES. VERBATIM: RELATIVE OF CONSUMER REPORTED NO EXPIRATION DATE ON A BOX OF RELION SYRINGES. STATED THE SYRINGES WERE PURCHASED IN 2015 AND SOME WERE USED. ADVISED THAT THIS PRODUCT BOX WOULD BE EXPIRED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. THE CUSTOMER'S ADDRESS IS (B)(6) HAS BEEN USED AS A DEFAULT. 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 SYRINGE 0.3ML 29GA 12.7MM 10BAG 500 WAL WAS MISSING THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328510 BATCH NO: 5180853. IT WAS REPORTED NO EXPIRATION DATE ON A BOX OF RELION SYRINGES. VERBATIM: RELATIVE OF CONSUMER REPORTED NO EXPIRATION DATE ON A BOX OF RELION SYRINGES. STATED THE SYRINGES WERE PURCHASED IN 2015 AND SOME WERE USED. ADVISED THAT THIS PRODUCT BOX WOULD BE EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404021 SYRINGE 0.3ML 29GA 12.7MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328510 5180853 00681131311663

    Patients

    Seq Age Sex Outcome Treatment
    1