BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 14056328 · Received April 8, 2022

    Report

    Report Number
    3003152976-2022-00135
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 21, 2022
    Report Date
    April 28, 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

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RECONSTITUTED CYCLOPHOSPHAMIDE LEAKED PAST THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PLUNGER WHEN ADDING IT TO A BAG OF NACL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE PREPARER DREW UP THE RECONSTITUTED CYCLOPHOSPHAMIDE SOLUTION WITH THE ABOVE SYRINGE. HE THEN STARTED TO ADD THE CYCLOPHOSPHAMIDE SOLUTION TO A BAG OF NACL. DURING THIS ADDITION, THE PRODUCT CONTAINED IN THE SYRINGE CAME OUT THROUGH THE PLUNGER AND DRIPPED ONTO THE FIELD AND GLOVES OF THE PREPARER. THERE WAS NO SKIN CONTACT AS THE PREPARER WAS DOUBLE GLOVED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RECONSTITUTED CYCLOPHOSPHAMIDE LEAKED PAST THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PLUNGER WHEN ADDING IT TO A BAG OF NACL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE PREPARER DREW UP THE RECONSTITUTED CYCLOPHOSPHAMIDE SOLUTION WITH THE ABOVE SYRINGE. HE THEN STARTED TO ADD THE CYCLOPHOSPHAMIDE SOLUTION TO A BAG OF NACL. DURING THIS ADDITION, THE PRODUCT CONTAINED IN THE SYRINGE CAME OUT THROUGH THE PLUNGER AND DRIPPED ONTO THE FIELD AND GLOVES OF THE PREPARER. - THERE WAS NO SKIN CONTACT AS THE PREPARER WAS DOUBLE GLOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283848 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2201069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown