BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE/NEEDLE COMBINATION

    MDR report key: 8155659 · Received December 12, 2018

    Report

    Report Number
    1213809-2018-00933
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 23, 2018
    Report Date
    March 20, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A LOT WAS ADDED TO THE COMPLAINT. MEDICAL DEVICE LOT #: 8203556. MEDICAL DEVICE EXPIRATION DATE: N/A. DEVICE MANUFACTURE DATE: 7/28/2018. INVESTIGATION SUMMARY: TWO SAMPLE BAGS CONTAINING USED 3ML SYRINGES WITH NEEDLES ATTACHED WERE RECEIVED. ALL SAMPLES APPEARED TO BE USED AND CONTAMINATED AND THEREFORE WERE EVALUATED THROUGH THE BAGS. ONE BAG CONTAINED 4 SYRINGES (3 WITH NEEDLES) AND UNIDENTIFIED RESIDUE INSIDE THE SAMPLES. THE BARRELS WERE OBSERVED TO HAVE CRACKS APPROXIMATELY 1.5¿ EXTENDING LENGTHWISE ALONG THE BARREL WALL. ONE BAG CONTAINED 1 SYRINGE WITH NEEDLE. THE BAG WAS MARKED WITH BATCH #8203556. THE SYRINGE WAS OBSERVED TO HAVE AN INSECURE STOPPER. UNIDENTIFIED RESIDUE WAS OBSERVED IN THE FLUID PATH AND AROUND THE STOPPER RIBS OF THE SAMPLE FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. MACHINE LOGS REVIEW REVEALED A TEMPORARY RAIL JAM DURING ASSEMBLY OF THIS BATCH WHICH REQUIRED ASSOCIATE¿S INTERVENTION. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS LIKELY ASSOCIATED WITH THE JAM DURING THE ASSEMBLY PROCESS. POTENTIAL ROOT CAUSE FOR THE INSECURE STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS CRACKED BARRELS: IMMEDIATE CORRECTIONS TOOK PLACE DURING THE MANUFACTURE OF THE BATCH. THE LIKELY CAUSE OF THE CRACKED BARRELS APPEARS TO HAVE BEEN AN ISOLATED ISSUE THAT AFFECTED A SMALL NUMBER OF BARRELS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. INSECURE STOPPER: NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE/NEEDLE COMBINATION HAD CRACKS IN THEM WHICH CAUSES THEM TO LEAK. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ SYRINGE/NEEDLE COMBINATION HAD CRACKS IN THEM WHICH CAUSES THEM TO LEAK. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998096 BD¿ SYRINGE/NEEDLE COMBINATION SYRINGE AND NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 8206917

    Patients

    Seq Age Sex Outcome Treatment
    1 Other