BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL EURO 125 S/C

    MDR report key: 11905058 · Received May 28, 2021

    Report

    Report Number
    1213809-2021-00383
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    April 29, 2021
    Report Date
    May 18, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: TWO PHOTOS OF TWO LOOSE 5ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED BOTH SYRINGES HAD A SINGLE LENGTHWISE CRACK PRESENT IN THE BARREL WALL THROUGH THE NUMERICAL PORTION OF THE SCALE. ONE SYRINGE HAD THE CRACK EXTENDING FROM THE 1ML MARKING TO THE 2.5ML GRAD LINE. ONE SYRINGE HAD THE CRACK EXTENDING FROM THE ZERO LINE TO THE 4ML MARKING. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0213256 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGE 5ML LL EURO 125 S/C WERE DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " DURING THE WITHDRAWAL OF WATER FOR THE RECONSTITUTION OF A VIAL OF VIDAZA, THE CRACK IN THE BODY OF A SYRINGE (WHICH HAD NOT BEEN DETECTED UNTIL THEN) CAUSED WATER TO BE PROJECTED INTO THE ISOLATOR DEDICATED TO THE PREPARATION OF CHEMOTHERAPY. THEN, WHEN RECONSTITUTING VIALS OF VIDAZA, A SYRINGE WITH A CRACKED BARREL WAS OBSERVED. THE SYRINGE HAD BEEN IN CONTACT WITH THE CYTOTOXIC SUBSTANCE. NO CLINICAL CONSEQUENCES FOR THE OPERATOR OR THE PATIENT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800646 SYRINGE 5ML LL EURO 125 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309649 0213256 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1