BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8306515 · Received February 5, 2019

    Report

    Report Number
    3003152976-2019-00129
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 15, 2019
    Report Date
    February 19, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE SAMPLE UNIT WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. THROUGH VISUAL INSPECTION OF THE SAMPLE, NO DAMAGES OR MOLDING DEFECTS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1810220 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. SILICONE CONTENT TESTS, BREAKOUT TESTS, AND SUSTAINING FORCE TESTS ARE PERFORMED FOR EVERY LOT NUMBER MANUFACTURED. THE TEST RESULTS FOR LOT NUMBER 1810220 WERE ALL WITHIN LIMITS. BASED ON THE INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE HAD DIFFICULT PLUNGER MOVEMENT DURING USE WITH A FRESENIUS VIAL PUMP.

    Additional Manufacturer Narrative · 1

    (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 HAD DIFFICULT PLUNGER MOVEMENT DURING USE WITH A FRESENIUS VIAL PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102037 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1810220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other