BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 11490227 · Received March 15, 2021

    Report

    Report Number
    1920898-2021-00293
    Event Type
    Malfunction
    Date Received
    March 15, 2021
    Date of Event
    February 14, 2021
    Report Date
    April 6, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311748
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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: 2021-04-05. INVESTIGATION SUMMARY: CUSTOMER RETURNED A SINGLE SYRINGE IN A POUCH LABELED FOR 1ML, 31 GAUGE, 8MM SYRINGES FROM LOT 0090428. THE SYRINGE NEEDLE IS BROKEN AND JAGGED WITH THE BREAKAGE CLOSE TO THE BARREL OF THE SYRINGE. TORQUING THE SYRINGE AND THUS NEEDLE TO ONE SIDE MAY HAVE RESULTED IN THE NEEDLE BUTTING UP AGAINST THE WALL OF THE VIAL. HIGH STRESSES COULD BE SIGNIFICANT ENOUGH FOR IT TO FRACTURE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0090428. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLE RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE NEEDLE BREAKING. THE ROOT CAUSE OF THE NEEDLE BREAKING MAY BE ACCIDENTALLY TORQUING THE SYRINGE WHILE INSIDE OF AN ASSOCIATED VIAL, PLACING SUFFICIENT STRESS ON THE NEEDLE TO BREAK IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328506, BATCH NO. 0904205. IT WAS REPORTED THAT NEEDLE BROKE OFF IN VIAL WHILE DRAWING UP INSULIN.

    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. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328506 BATCH NO. 0904205. IT WAS REPORTED THAT NEEDLE BROKE OFF IN VIAL WHILE DRAWING UP INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377550 SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328506 UNKNOWN 00681131311748

    Patients

    Seq Age Sex Outcome Treatment
    1