BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 10668534 · Received October 13, 2020

    Report

    Report Number
    1920898-2020-01393
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    September 21, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: 2020-10-23. INVESTIGATION SUMMARY: CUSTOMER RETURNED THREE (3) LOOSE 31GX6MM, 0.3ML BD INSULIN SYRINGES FROM LOT: 0041282. CONSUMER REPORTED THAT NEEDLE HUB SEPARATED INTO SHIELDS. ALL 3 SYRINGES WERE EXAMINED, AND NO HUB SEPARATION WAS OBSERVED; REMOVING THE CANNULA SHIELDS FROM THESE SYRINGES DID NOT RESULT IN HUB SEPARATION. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECTS WERE OBSERVED, THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 0041282 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SYRINGE 0.3ML 31GA 6MM WHOLE UNIT 10 BAG SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE HUB SEPARATED INTO SHIELDS. CONSUMER REPORTED ADULT SON FINDING QUITE A FEW FROM THIS BOX NEEDLE HUB".

    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 AN UNSPECIFIED NUMBER OF BD SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE HUB SEPARATED INTO SHIELDS. VERBATIM: CONSUMER REPORTED ADULT SON FINDING QUITE A FEW FROM THIS BOX NEEDLE HUB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134210 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 0041282 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other