BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL

    MDR report key: 11291245 · Received February 8, 2021

    Report

    Report Number
    1920898-2021-00163
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 15, 2021
    Report Date
    March 5, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1/2CC, 8MM, 31G RELION SYRINGE IN AN OPEN POLY BAG FROM LOT # 0083446. CUSTOMER STATES THAT THE PLUNGER CAP LOOKED LIKE IT HAD BEEN CHEWED BY A MACHINE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A CRUSHED PLUNGER CAP. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0083446. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL PLUNGER CAP WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328509 BATCH NO: UNKNOWN. IT WAS REPORTED THAT ONE SYRINGE HAD A PLUNGER CAP THAT LOOKED LIKE IT HAD BEEN CHEWED BY A MACHINE. VERBATIM: PHARMACIST CALLED TO REPORT ISSUE ON BEHALF OF CONSUMER. STATED ONE RELION SYRINGE LOOKS AS IF THE PLUNGER CAP WAS CHEWED BY A MACHINE. ONE SYRINGE AFFECTED. STATED SHE HAS REPORTED PREVIOUS COMPLAINTS ON BEHALF OF THIS CONSUMER. ADVISED THAT ONLY A MAIL KIT WOULD BE SENT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL PLUNGER CAP WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328509 BATCH NO: UNKNOWN IT WAS REPORTED THAT ONE SYRINGE HAD A PLUNGER CAP THAT LOOKED LIKE IT HAD BEEN CHEWED BY A MACHINE. VERBATIM: PHARMACIST CALLED TO REPORT ISSUE ON BEHALF OF CONSUMER. STATED ONE RELION SYRINGE LOOKS AS IF THE PLUNGER CAP WAS CHEWED BY A MACHINE. ONE SYRINGE AFFECTED. STATED SHE HAS REPORTED PREVIOUS COMPLAINTS ON BEHALF OF THIS CONSUMER. ADVISED THAT ONLY A MAIL KIT WOULD BE SENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194703 SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328509 UNKNOWN 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1