BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿ II NEEDLE

    MDR report key: 7971447 · Received October 16, 2018

    Report

    Report Number
    1920898-2018-00783
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    September 24, 2018
    Report Date
    October 25, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908820011
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED (5) 1CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7170628. CUSTOMER STATES THAT THE SYRINGES HAVE A DEFORMED STOPPER. ALL RETURNED SYRINGES WERE EXAMINED AND 3 OUT OF 5 SYRINGES EXHIBITED A DEFORMED STOPPER IN THE BARREL. ALSO, ONE SYRINGE WAS RETURNED WITH THE NEEDLE PART OF THE BARREL BROKEN OFF AND STUCK IN THE SHIELD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7170628. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS [200703785, 200703956, 200693868, 200693816, 200703957] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. TWO OF THE RETURNED SAMPLE WERE FOUND TO HAVE CANNULA SEPARATES FROM THE REMAINDER OF THE DEVICE. ADDITIONALLY, THE SAMPLES WERE VISUALLY INSPECTED UNDER ULTRAVIOLET LIGHT TO VERIFY THE PRESENCE OF ADHESIVE (EPOXY) ON THE SIDE OF THE BARREL TIPS. IN BOTH CASES, THE MATERIAL FLUORESCED, INDICATING THAT IS MOST LIKELY ADHESIVE UTILIZED FOR CURING OF THE CANNULA WITH THE BARREL. (B)(4) WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS 1ML CUSTOMER COMPLAINTS, SPECIFICALLY CANNULA SEPARATES AND BENT CANNULA, AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 7170628 WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF CORRECTIVE/PREVENTIVE ACTIONS ASSOCIATED WITH THIS CAPA. BASED ON THE SAMPLES/PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DEFORMED STOPPER AND BROKEN BARREL). PROBABLE ROOT CAUSE FOR THE DEFORMED STOPPERS IS LIKELY TO BE INSUFFICIENT SILICONE WITHIN THE BARRELS PRIOR TO ASSEMBLY OF THE PLUNGER ROD/STOPPER WITHIN THE SYRINGE. WHEN THIS TYPE OF EVENT OCCURS, DEFORMATIONS OF THE STOPPER CAN OCCUR AND PASS THROUGH THE MANUFACTURING PROCESS WITHOUT BEING DETECTED. PROBABLE ROOT CAUSE FOR THE MISSING CANNULAS IS LIKELY INCOMPLETE CURING OF THE CANNULA WITHIN THE SYRINGE BARREL DUE TO ADHESIVE RUN-OVER ONTO THE BARREL TIP. WHEN THIS TYPE OF EVENT OCCURS, INSUFFICIENT ADHESIVE REQUIRED TO PERMANENTLY AFFIX THE CANNULA WITHIN THE DEVICE MAY HAVE AN INCREASED PROBABILITY OF OCCURRENCE. THE CANNULA MAY BECOME DISLODGED DURING TRANSPORTATION OR DURING INITIAL ACTIVATION OF THE DEVICE BY THE END USER. IN EITHER EVENT, THE DEVICE IS RENDERED INOPERABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INSULIN SYRINGE WITH THE BD ULTRA FINE II NEEDLE HAD A DEFORMED STOPPER AND BROKEN BARREL. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿ II NEEDLE HAD A DEFORMED STOPPER AND BROKEN BARREL. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810810 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿ II NEEDLE SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 7170628 00382908820011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other