BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 14160223 · Received April 20, 2022

    Report

    Report Number
    3003152976-2022-00159
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 29, 2022
    Report Date
    May 19, 2022
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: MULTIPLE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE TIP IS OBSERVED TO BE BROKEN IN ONE OF THE SYRINGES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2110137, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED WITHIN ANY OF THE TIPS. 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, INCLUDING TIP AND THREAD VERIFICATION TESTING. ALL RESULTS WERE REVIEWED FOR LOT 2110137 AND FOUND TO BE WITHIN SPECIFICATION. BASED ON OUR INVESTIGATION AND GIVEN THE DEVICE RECORDS DID NOT IDENTIFY ANY FAILURES RELATED TO THIS INCIDENT, WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE BROKE OFF INSIDE THE DIFFUSER CONNECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE NURSE USED IT TO FILL A BBRAUN EASYPUMP 270ML DIFFUSER. SHE WAS ABLE TO FIT THE SYRINGE AND FILL AS USUAL BUT ON REMOVAL THE LUER-LOCK TIP BROKE OFF INSIDE THE DIFFUSER CONNECTOR. THERE WAS NO UNUSUAL HANDLING, AND SHE DID NOT FORCE IT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE BROKE OFF INSIDE THE DIFFUSER CONNECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE NURSE USED IT TO FILL A BBRAUN EASYPUMP 270ML DIFFUSER. SHE WAS ABLE TO FIT THE SYRINGE AND FILL AS USUAL BUT ON REMOVAL THE LUER-LOCK TIP BROKE OFF INSIDE THE DIFFUSER CONNECTOR. THERE WAS NO UNUSUAL HANDLING, AND SHE DID NOT FORCE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2630998 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110137

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown