BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 11174932 · Received January 14, 2021

    Report

    Report Number
    3003152976-2021-00031
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Date of Event
    December 21, 2020
    Report Date
    January 7, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. (B)(4). INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1902359, FINDING ONE ANNOTATION THAT MAY BE RELATED TO THE REPORTED FAILURE. DURING THE ASSEMBLY PROCESS, AN INCIDENT WAS DETECTED DURING THE FEEDING OF THE BARRELS INTO THE ASSEMBLY MACHINE. AS A RESULT THE BARRELS JAMMED WITHIN THE MACHINE CAUSING DAMAGE TO THE PRODUCT. ONCE DETECTED, THE MECHANICAL TEAM REPAIRED THE FAILURE AND (B)(4) UNITS WERE SCRAPPED. 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. BASED ON OUR INVESTIGATION IT WAS DETERMINED THIS INCIDENT IS LIKELY RELATED TO THE FAILURE IDENTIFIED DURING MANUFACTURING, THE IMPACTED UNIT NOT PROPERLY DISCARDED. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS DURING INSPECTIONS. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. NO RETAINED SAMPLES CAN BE EVALUATED SINCE THERE ARE NOT RETAINED SAMPLES AVAILABLE FOR BULK REFERENCES SO LEAK TEST ACCORDING TO ISO-7886-1 ANNEX D CANNOT BE DONE. LEAK TEST IS PERFORMED TO EVERY SYRINGE IN ASSEMBLY STATION DURING MANUFACTURING PROCESS. IN CASE ANY FAILS IT IS REJECTED TO SCRAP AUTOMATICALLY. ACCORDING TO THE FINDING IN DHR REVIEW, THE ROOT CAUSE OF THE LEAKAGE DEFECT IS DAMAGE ON SYRINGE BARREL CAUSED BY THE FAILURE DETECTED IN ASSEMBLY PROCESS OF LOT 1902359.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE LEAKED PAST THE PLUNGER STOPPER AND HAD SCRATCHES ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "LEAK IN THE RUBBER OF THE SYRINGE PLUNGER. THE SYRINGE ALSO HAS TWO LARGE SCRATCHES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65844 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1902359

    Patients

    Seq Age Sex Outcome Treatment
    1