BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10137395 · Received June 10, 2020

    Report

    Report Number
    3003152976-2020-00248
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    May 19, 2020
    Report Date
    July 30, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES. D.10 RETURNED TO MANUFACTURER ON: 2020-07-22. INVESTIGATION SUMMARY: ONE SAMPLE AND FOUR PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTION OF THE SAMPLES AND PHOTO, THE SYRINGE TIP IS OBSERVED TO BE BROKEN, DETACHED FROM THE BARREL THREAD. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2001234, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TIP AND THREAD VERIFICATION TESTS ARE PERFORMED WITHIN THE MANUFACTURING ENVIRONMENT ACCORDING TO PROCEDURE. RESULTS WERE REVIEWED FOR LOT 2001234 AND FOUND TO BE WITHIN SPECIFICATION. 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. THE AREAS WHERE PRODUCT MOVES WITHIN THE MANUFACTURING EQUIPMENT IS PROTECTED TO AVOID ANY DAMAGE TO THE PRODUCT. IT HAS BEEN DETERMINED THAT THE TIP BREAKAGE OCCURRED DUE TO OVER-SCREW DURING THE CONNECTION OF THE SYRINGE DURING USE BY CUSTOMER. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGES EXPERIENCED THE TIP/LUER OF SYRINGE BREAKING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PLACING THE SYRINGE ON THE ELASTOMERIC PUMP, THE LUER-LOOK CONE HAS BEEN TWISTED OFF AND KINKED WHEN SCREWING AND LOCKING ONTO THE THREAD OF THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). 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 AN UNSPECIFIED NUMBER OF BD PLASTIPAK¿ 50 ML CONCENTRIC LUER LOCK SYRINGES EXPERIENCED THE TIP/LUER OF SYRINGE BREAKING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PLACING THE SYRINGE ON THE ELASTOMERIC PUMP, THE LUER-LOOK CONE HAS BEEN TWISTED OFF AND KINKED WHEN SCREWING AND LOCKING ONTO THE THREAD OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605264 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2001234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other