BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS

    MDR report key: 11121795 · Received January 6, 2021

    Report

    Report Number
    1920898-2021-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 8, 2020
    Report Date
    January 26, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 12/28/2020 . H.6. INVESTIGATION: CUSTOMER RETURNED (3) 1/2CC, 8MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 0174632. CUSTOMER STATES THAT THE HUB ASSEMBLY REMAINED IN THE NEEDLE SHIELDS AND THAT THE SYRINGES HAD THE SHIELDS LOOSE IN THE BAG. ALL RETURNED SYRINGES WERE EXAMINED AND ALL EXHIBITED A BROKEN BARREL TIP, WHICH WILL BE INVESTIGATED UNDER INVESTIGATION CHILD 2160821. NO HUB ASSEMBLY SEPARATION WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0174632. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200898951, 200898499] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATIONS [200897792] NOTED FOR HIGH SHIELD PULLS. ROOT CAUSE: L2L #103316 DISPATCH CORRECTED THE ISSUE BY OILING THE SLIDES GOING INTO THE FIRST INDEX DIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS NEEDLE HUB SEPARATED ON 3 OCCASION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 328468 BATCH NO.: 0174632. IT WAS REPORTED THAT THE HUB ASSEMBLY REMAINED IN THE NEEDLE SHIELDS AND THREE SYRINGES HAD THE SHIELDS LOOSE IN THE BAG. PER SNOW: CONSUMER REPORTED FOUND 3 SYRINGE IN THIS ONE BAG NEEDLE SHIELDS WITH NEEDLE HUB ASSEMBLY INSIDE SHIELD, AND JUST LAYING IN THE BAG. THREE SYRINGE BARRELS WITHOUT THE NEEDLE SHIELDS ALSO IN THE BAG.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS NEEDLE HUB SEPARATED ON 3 OCCASION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 328468, BATCH NO.: 0174632. IT WAS REPORTED THAT THE HUB ASSEMBLY REMAINED IN THE NEEDLE SHIELDS AND THREE SYRINGES HAD THE SHIELDS LOOSE IN THE BAG. PER (B)(6): CONSUMER REPORTED FOUND 3 SYRINGE IN THIS ONE BAG NEEDLE SHIELDS WITH NEEDLE HUB ASSEMBLY INSIDE SHIELD, AND JUST LAYING IN THE BAG. THREE SYRINGE BARRELS WITHOUT THE NEEDLE SHIELDS ALSO IN THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19545 SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328468 0174632 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1