BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SYRINGE 3ML LL 200 S/C

    MDR report key: 12206903 · Received July 21, 2021

    Report

    Report Number
    1920898-2021-00801
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    May 17, 2021
    Report Date
    August 13, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE SAMPLES WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE RETURNED SAMPLES OF SHIPPING CARTONS SHRINK WRAPPED TOGETHER WITH THE REPORTED ISSUE OF ¿NO LABELS ON THE CASES¿. THE RETURNED SHIPPING CARTONS WERE EXAMINED AND NO LABEL WAS ATTACHED TO THE SHIPPING CARTONS OR THE SHRINK WRAP. THERE IS NO INDICATION OF THE PRODUCT OR LOT INFORMATION ON THE OUTSIDE OF THE SHIPPING CARTONS. A DHR REVIEW WAS NOT PERFORMED AS THE LOT NUMBER IS "UNKNOWN" FOR THIS COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 CASES OF SYRINGE 3ML LL 200 S/C WERE RECEIVED WITHOUT LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SINCE THERE IS NO LABELS ON THESE CASES, I DON¿T KNOW IF THEY CAN TELL YOU THE BATCH # ON THESE CASES. IT IS MY UNDERSTANDING THAT THEY HAVE ONE CASE OF EACH ONE OF THE FOLLOWING SHIPMENTS."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE POTENTIAL LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1047003, MEDICAL DEVICE EXPIRATION DATE: 01/31/2026, DEVICE MANUFACTURE DATE: 02/16/2021. MEDICAL DEVICE LOT #: 1047017, MEDICAL DEVICE EXPIRATION DATE: 01/31/2026, DEVICE MANUFACTURE DATE: 02/16/2021. MEDICAL DEVICE LOT #: 1063003, MEDICAL DEVICE EXPIRATION DATE: 02/28/2026, DEVICE MANUFACTURE DATE: 03/04/2021. MEDICAL DEVICE LOT #: 1063005, MEDICAL DEVICE EXPIRATION DATE: 02/28/2026, DEVICE MANUFACTURE DATE: 03/04/2021. MEDICAL DEVICE LOT #: 1077832, MEDICAL DEVICE EXPIRATION DATE: 03/31/2026, DEVICE MANUFACTURE DATE: 03/18/2021. MEDICAL DEVICE LOT #: 1077834, MEDICAL DEVICE EXPIRATION DATE: 03/31/2026, DEVICE MANUFACTURE DATE: 03/18/2021. MEDICAL DEVICE LOT #: 1077836, MEDICAL DEVICE EXPIRATION DATE: 03/31/2026, DEVICE MANUFACTURE DATE: 03/18/2021. MEDICAL DEVICE LOT #: 1077841, MEDICAL DEVICE EXPIRATION DATE: 03/31/2026, DEVICE MANUFACTURE DATE: 03/18/2021. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 CASES OF SYRINGE 3ML LL 200 S/C WERE RECEIVED WITHOUT LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SINCE THERE IS NO LABELS ON THESE CASES, I DON'T KNOW IF THEY CAN TELL YOU THE BATCH # ON THESE CASES. IT IS MY UNDERSTANDING THAT THEY HAVE ONE CASE OF EACH ONE OF THE FOLLOWING SHIPMENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101425 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1