BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8596357 · Received May 9, 2019

    Report

    Report Number
    3003152976-2019-00317
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 24, 2019
    Report Date
    May 23, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE USED SAMPLE UNIT AND FOUR PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. VISUAL INSPECTION OF THE SAMPLE REVEALED THE SYRINGE TIP WAS BROKEN AND REMAINED ATTACHED TO THE EXTENSION SET. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 1812237 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TIP AND THREAD VERIFICATION TESTS ARE PERFORMED WITHIN THE MANUFACTURING ENVIRONMENT ACCORDING TO PROCEDURE. IT HAS BEEN DETERMINED THAT THE TIP BREAKAGE OCCURRED DUE TO OVER-SCREW DURING THE CONNECTION OF THE SYRINGE BY THE USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE DISCONNECTED FROM THE EXTENSION SET DUE TO TIP BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "DURING AN INTERVENTION, THE NURSE CONNECTED THE SYRINGE TO THE EXTENSION SET, THE 2 DEVICES THEN DISCONNECTED WITH TIP BREAKAGE OF THE SYRINGE IN THE EXTENSION SET. THIS PROBLEM HAPPENED TWICE IN A ROW."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). 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 THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE DISCONNECTED FROM THE EXTENSION SET DUE TO TIP BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DURING AN INTERVENTION, THE NURSE CONNECTED THE SYRINGE TO THE EXTENSION SET, THE 2 DEVICES THEN DISCONNECTED WITH TIP BREAKAGE OF THE SYRINGE IN THE EXTENSION SET. THIS PROBLEM HAPPENED TWICE IN A ROW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387530 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1812237

    Patients

    Seq Age Sex Outcome Treatment
    1 Other