BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 11683609 · Received April 18, 2021

    Report

    Report Number
    3003152976-2021-00203
    Event Type
    Malfunction
    Date Received
    April 18, 2021
    Date of Event
    March 22, 2021
    Report Date
    May 17, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/21/2021. H.6. INVESTIGATION: ONE CASE OF UNUSED PRODUCT FROM LOT 2010073 WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, THERE ARE NO DEFECTS OR DAMAGE NOTED ON ANY OF THE SAMPLES OR SYRINGE COMPONENTS AND THE STOPPERS WERE VERIFIED TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER ROD. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2010073, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE RETURNED SAMPLES UNDERWENT THESE TESTS AND IN ALL CASES THE PRODUCT MET REQUIRED SPECIFICATION. GIVEN THAT NO DEFECTS WERE OBSERVED IN THE RETURNED SAMPLES AND PRODUCT MET REQUIRED LIMITS DURING LEAKAGE TESTING, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGES EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INIITAL REPORTER: WHEN PRODUCING CYTOSTATIC DRUGS WHEN DRAWING UP THE SYRINGE, THE LIQUID HAS LEAKED OUT OF THE BACK OF 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, A SUPPLEMENTAL REPORT WILL BE FILED. INITIAL REPORTER PHONE #: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGES EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PRODUCING CYTOSTATIC DRUGS WHEN DRAWING UP THE SYRINGE, THE LIQUID HAS LEAKED OUT OF THE BACK OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580932 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2010073

    Patients

    Seq Age Sex Outcome Treatment
    1