BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 11276155 · Received February 3, 2021

    Report

    Report Number
    1920898-2021-00147
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 12, 2021
    Report Date
    March 19, 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
    UT, US
    Reporter Occupation
    003

    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: 2/9/2021. H.6. INVESTIGATION: CUSTOMER RETURNED TWO SYRINGES WITH A SINGLE RELI-ON POUCH, INDICATING THAT THEY ARE 0.3ML 31 GAUGE 8MM SYRINGES FROM LOT 0132204. ONE SYRINGE WAS RETURNED WITH FULLY ASSEMBLED, BUT THE NEEDLE SHIELD COULD NOT BE REMOVED WITHOUT THE HUB SEPARATING FROM THE BARREL. THE REMAINING SYRINGE ALREADY FEATURED THE NEEDLE SHIELD AND HUB SEPARATED FROM THE BARREL. IN BOTH INSTANCES, THERE IS NO DAMAGE TO THE CONNECTOR AT THE DISTAL TIP OF THE BARREL NOR THE BASE OF THE NEEDLE HUB. NO SIGNS OF USE. NO OTHER DEFECTS FOUND. HUB SEPARATION CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0132204. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 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 NEEDLE HUB SEPARATED INTO THE SHIELD. VERBATIM: CONSUMER REPORTED NEEDLE HUB SEPARATED INSIDE OF THE SHIELD."

    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)(6)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 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 NEEDLE HUB SEPARATED INTO THE SHIELD. VERBATIM: CONSUMER REPORTED NEEDLE HUB SEPARATED INSIDE OF THE SHIELD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168867 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 0132204 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1