BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8735105 · Received June 26, 2019

    Report

    Report Number
    3003152976-2019-00421
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    June 4, 2019
    Report Date
    August 7, 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

    H.6. INVESTIGATION: ONE SAMPLE AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UPON VISUAL INSPECTION, WE WERE ABLE TO OBSERVE THE SYRINGE BARREL WAS BROKEN AT THE BARREL EDGE. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 1904226. PRODUCT IS TESTED AND INSPECTED ACCORDING TO PROCEDURE TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. BASED ON THE AVAILABLE INFORMATION WE ARE UNABLE TO DETERMINE A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE BROKE UNDER THE PRESSURE PLACED ON THE LUER-LOCK FROM THE HEALTH PROFESSIONAL WHILE WITHDRAWING THE SALINE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WHEN ABOUT TO PREPARE AN INSULINE SYRINGE, TAKING OUT THE SALINE, A BIG PRESSURE HAS BEEN CREATED. THE SYRINGE HAS BROKEN UNDER THE PRESSURE MADE BY THE HEALTH PROFESSIONAL AT LUER LOCK POINT."

    Additional Manufacturer Narrative · 1

    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 BROKE UNDER THE PRESSURE PLACED ON THE LUER-LOCK FROM THE HEALTH PROFESSIONAL WHILE WITHDRAWING THE SALINE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN ABOUT TO PREPARE AN INSULIN SYRINGE, TAKING OUT THE SALINE, A BIG PRESSURE HAS BEEN CREATED. THE SYRINGE HAS BROKEN UNDER THE PRESSURE MADE BY THE HEALTH PROFESSIONAL AT LUER LOCK POINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531581 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1904226

    Patients

    Seq Age Sex Outcome Treatment
    1 Other