BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ - 3-PIECE SYRINGE

    MDR report key: 14137477 · Received April 18, 2022

    Report

    Report Number
    3003152976-2022-00152
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 25, 2022
    Report Date
    October 3, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K182589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H6: INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2201069, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2201069 WERE USED TO FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED ON ANY OF THE SAMPLES OR COMPONENTS, THE STOPPER WAS PROPERLY ASSEMBLED ON THE PLUNGER, AND IN ALL CASES NO LEAKAGE WAS OBSERVED. 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 LEAKAGE TESTING. RESULTS WERE REVIEWED AND PRODUCT WAS VERIFIED TO MEET REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD PLASTIPAK¿ - 3-PIECE SYRINGE, LEAKAGE PAST THE STOPPER WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS WHEN THE PREPARER PULLED THE PLUNGER TO DRAW IN THE OXALIPLATIN (CYTOTOXIC) SOLUTION THAT HE NOTICED AN ABNORMAL INGRESS OF AIR AND THAT THE OXALIPLATIN BEGAN TO FLOW DOWN THE PLUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD PLASTIPAK¿ - 3-PIECE SYRINGE, LEAKAGE PAST THE STOPPER WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS WHEN THE PREPARER PULLED THE PLUNGER TO DRAW IN THE OXALIPLATIN (CYTOTOXIC) SOLUTION THAT HE NOTICED AN ABNORMAL INGRESS OF AIR AND THAT THE OXALIPLATIN BEGAN TO FLOW DOWN THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2715955 BD PLASTIPAK¿ - 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2201069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown