BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 11168467 · Received January 13, 2021

    Report

    Report Number
    1920898-2021-00056
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 20, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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: 1/11/2021. H6 INVESTIGATION: CUSTOMER RETURNED (4) 3/10CC, 8MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 9231336. CUSTOMER STATES THAT NEEDLE HUBS SEPARATED INTO SHIELD. ALL RETURNED SYRINGES WERE EXAMINED AND 2 OUT OF 4 SAMPLES EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. NO DEFECTS WERE OBSERVED ON THE REMAINING SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9231336 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE NOTIFICATION [200872529] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO NOTIFICATIONS [200872129, 200872284] NOTED FOR CRACKED HUBS. NOTIFICATION #200872129 WAS CREATED CRACKED HUBS MAINTENANCE DISPATCH (L2L) #91271 WAS OPENED FOR RAISED HUBS CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT 3 SYRINGES NEEDLE HUBS SEPARATED INTO SHIELD. VERBATIM: CONSUMER REPORTED FOUND 3 SYRINGES NEEDLE HUB ASSEMBLY STAYED IN THE NEEDLE SHIELD WHEN REMOVED FROM SYRINGE."

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT 3 SYRINGES NEEDLE HUBS SEPARATED INTO SHIELD. CONSUMER REPORTED FOUND 3 SYRINGES NEEDLE HUB ASSEMBLY STAYED IN THE NEEDLE SHIELD WHEN REMOVED FROM SYRINGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55153 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 9231336 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1