BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 8637011 · Received May 23, 2019

    Report

    Report Number
    3003152976-2019-00342
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    May 8, 2019
    Report Date
    June 20, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UPON VISUAL INSPECTION, THE THREADING ON THE SYRINGE WAS OBSERVED TO BE DAMAGED. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 1903219 . TIP AND THREAD VERIFICATION TESTS ARE PERFORMED WITHIN THE MANUFACTURING ENVIRONMENT ACCORDING TO PROCEDURE. THE SYRINGE RECEIVED AND THREADING HAVE BEEN VERIFIED AND FOUND TO BE COMPLIANT WITH STANDARDS. IT HAS BEEN DETERMINED THIS INCIDENT OCCURRED DUE TO OVER-SCREW DURING THE CONNECTION OF THE SYRINGE WHICH RESULTED IN THE PRODUCT NOT PROPERLY ATTACHING. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LOOSE SAFETY MECHANISM OCCURRED WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "UNFORTUNATELY WE HAVE HAD A PROBLEM WITH ONE OF YOUR 50ML LUERLOCK SYRINGES. THE SYRINGE WAS BEING USED TO DRAW UP MEDICATION FOR AN INFUSION BUT IT WAS NOT POSSIBLE TO ATTACH IT SECURELY TO A SYRINGE EXTENSION SET AS IT KEPT TURNING CONTINUOUSLY AND WOULD NOT LOCK INTO PLACE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 LOOSE SAFETY MECHANISM OCCURRED WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "UNFORTUNATELY WE HAVE HAD A PROBLEM WITH ONE OF YOUR 50ML LUERLOCK SYRINGES. THE SYRINGE WAS BEING USED TO DRAW UP MEDICATION FOR AN INFUSION BUT IT WAS NOT POSSIBLE TO ATTACH IT SECURELY TO A SYRINGE EXTENSION SET AS IT KEPT TURNING CONTINUOUSLY AND WOULD NOT LOCK INTO PLACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428705 BD PLASTIPAK 50ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1903219

    Patients

    Seq Age Sex Outcome Treatment
    1 Other