BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 16709900 · Received April 10, 2023

    Report

    Report Number
    3003152976-2023-00125
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    February 28, 2023
    Report Date
    May 10, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE STOPPER WAS INCORRECTLY ASSEMBLED TO THE PLUNGER, DISTORTED AGAINST THE BARREL WALL. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 2211124. THIS ISSUE WAS DETERMINED TO HAVE OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT WHEN DRAWING SALINE FOR A PREPARATION THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THE STOPPER DISENGAGED FROM THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: WHEN DRAWING SALINE FOR A PREPARATION, THE STOPPER DISENGAGED FROM THE PLUNGER. CLINICAL CONSEQUENCES: MEDICATION PREPARATION IMPOSSIBLE TO PERFORM. THE CONCERNED DEVICE IS AT YOUR DISPOSAL IN OUR UNIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN DRAWING SALINE FOR A PREPARATION THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THE STOPPER DISENGAGED FROM THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: WHEN DRAWING SALINE FOR A PREPARATION, THE STOPPER DISENGAGED FROM THE PLUNGER. CLINICAL CONSEQUENCES: MEDICATION PREPARATION IMPOSSIBLE TO PERFORM. THE CONCERNED DEVICE IS AT YOUR DISPOSAL IN OUR UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532628 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2211124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown