BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8884814 · Received August 12, 2019

    Report

    Report Number
    3003152976-2019-00531
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 23, 2019
    Report Date
    September 25, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903008650
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT: 1905258, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT: 1905258 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THERE WAS LEAKAGE NOTICED BEHIND THE STOPPER. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WHEN PREPARING A BAG OF RITUXIMAB IN URC: THE RITUXIMAB IS TAKEN WITH A 60 ML LL SYRINGE. WHEN RITUMIXAB IS INJECTED INTO THE SOLVENT BAG, A FRACTION (1ML BUT NOT EVALUABLE) IS PASSED BEHIND THE PISTON OF THE SYRINGE USED FOR SINGLE USE (ONLY ONE SAMPLE TAKEN WITH THE SYRINGE).

    Additional Manufacturer Narrative · 1

    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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THERE WAS LEAKAGE NOTICED BEHIND THE STOPPER. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN PREPARING A BAG OF RITUXIMAB IN URC: THE RITUXIMAB IS TAKEN WITH A 60 ML LL SYRINGE. WHEN RITUMIXAB IS INJECTED INTO THE SOLVENT BAG, A FRACTION (>1ML BUT NOT EVALUABLE) IS PASSED BEHIND THE PISTON OF THE SYRINGE USED FOR SINGLE USE (ONLY ONE SAMPLE TAKEN WITH THE SYRINGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677944 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMI BECTON DICKINSON, S.A. 1905258 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other