BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 16798773 · Received April 24, 2023

    Report

    Report Number
    3003152976-2023-00146
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    February 23, 2023
    Report Date
    August 9, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 24-JUL-2023. H6: INVESTIGATION SUMMARY: ONE 50ML SYRINGE SAMPLE AND PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL EVALUATION, IT WAS OBSERVED THAT THE STOPPER WAS INCORRECTLY ASSEMBLED TO THE PLUNGER, DISTORTED AGAINST THE BARREL WALL, WHICH CAN LEAD TO LEAKAGE PAST STOPPER AND AIR BUBBLES. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 2212067. THIS ISSUE WAS DETERMINED TO HAVE OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H3: 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 THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE EXPERIENCED AIR BUBBLES 1 OF 3. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE SYRINGE CONTAINING THE CISATRACURIUM HAD AIR INSIDE, WITH A VOLUME OF ABOUT 25ML.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE EXPERIENCED AIR BUBBLES 1 OF 3. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE SYRINGE CONTAINING THE CISATRACURIUM HAD AIR INSIDE, WITH A VOLUME OF ABOUT 25ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601887 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2212067

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown