BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 11248668 · Received January 28, 2021

    Report

    Report Number
    1920898-2021-00135
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Date of Event
    January 8, 2021
    Report Date
    March 2, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 4251561,4345729, 5103814, & 5222582. ALL INSPECTIONS AND THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 15 BOXES OF SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT ONE BOX HAD NINE PACKAGES INSTEAD OF TEN AND 15 BOXES OF INSULIN SYRINGES DID NOT HAVE THE EXPIRATION DATES ON THEM. THE CONSUMER STATED SHE HAS 4 DIFFERENT SYRINGE SIZES SO 4 DIFFERENT COMPLAINT FILES WILL BE OPENED. VERBATIM: SPOUSE HAS ABOUT 15 BOXES OF INSULIN SYRINGES WITH NO EXPIRATION DATES ON THEM.STATED SHE HAS 4 DIFFERENT SYRINGE SIZES SO 4 DIFFERENT COMPLAINT FILES WILL BE OPENED. OTHER COMPLAINT FILES ARE (B)(4). STATED THE BOXES ARE UNOPENED.LOT # 4345729 - 2 BOXESLOT # 5103814 - 3 BOXESLOT # 5222582 - 1 BOXCAT # 328466DATE OF EVENT: UNKNOWN. SAMPLES: NO STATED 1 BOX ALSO HAD 9 PACKAGES INSTEAD OF 10 CAT # 328466 LOT # 4251561."

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5222582, DEVICE MANUFACTURE DATE: 2015-10-05. MEDICAL DEVICE LOT #: 5103814, DEVICE MANUFACTURE DATE: 2015-06-30. MEDICAL DEVICE LOT #: 4345729, DEVICE MANUFACTURE DATE: 2015-01-12. 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 15 BOXES OF SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT ONE BOX HAD NINE PACKAGES INSTEAD OF TEN AND 15 BOXES OF INSULIN SYRINGES DID NOT HAVE THE EXPIRATION DATES ON THEM. THE CONSUMER STATED SHE HAS 4 DIFFERENT SYRINGE SIZES SO 4 DIFFERENT COMPLAINT FILES WILL BE OPENED. VERBATIM: SPOUSE HAS ABOUT 15 BOXES OF INSULIN SYRINGES WITH NO EXPIRATION DATES ON THEM. STATED SHE HAS 4 DIFFERENT SYRINGE SIZES SO 4 DIFFERENT COMPLAINT FILES WILL BE OPENED. OTHER COMPLAINT FILES ARE (B)(4).STATED THE BOXES ARE UNOPENED. LOT # 4345729 - 2 BOXES, LOT # 5103814 - 3 BOXES, LOT # 5222582 - 1 BOX, CAT # 328466, DATE OF EVENT: UNKNOWN, SAMPLES: NO. STATED 1 BOX ALSO HAD 9 PACKAGES INSTEAD OF 10 CAT # 328466, LOT # 4251561."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144457 SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328466 4345729 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1