BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 13258421 · Received January 14, 2022

    Report

    Report Number
    3003152976-2021-00905
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 21, 2021
    Report Date
    February 9, 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

    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT CAN BE OBSERVED A SYRINGE WITH THE STOPPER MISASSEMBLED. NO ADDITIONAL DEFECTS CAN BE SEEN THAT COULD LEAD TO THE DEFECT NOTICED BY CUSTOMER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2110042 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. POSSIBLE ROOT CAUSE IS ASSOCIATED WHEN THERE IS A MISALIGNMENT OF PLUNGER-STOPPER-BARREL IN THE ASSEMBLY STATION DURING ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED A MISALIGNED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A QUALITY PROBLEM WAS OBSERVED BY THE CHEMOTHERAPY PRODUCTION DEPARTMENT AT THE PHARMACY. DURING THE PRODUCTION OF AN EMERGENCY CHEMOTHERAPY, IT WAS IMPOSSIBLE TO WITHDRAW THE CORRECT VOLUME OF SOLVENT FROM THE LUER-LOCK OF THE SYRINGE. THERE WERE NO CLINICAL CONSEQUENCES AS THE PRODUCT DID NOT REACH THE PATIENT, BUT THIS RESULTED IN A DELAY IN MANAGEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED A MISALIGNED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A QUALITY PROBLEM WAS OBSERVED BY THE CHEMOTHERAPY PRODUCTION DEPARTMENT AT THE PHARMACY. DURING THE PRODUCTION OF AN EMERGENCY CHEMOTHERAPY, IT WAS IMPOSSIBLE TO WITHDRAW THE CORRECT VOLUME OF SOLVENT FROM THE LUER-LOCK OF THE SYRINGE. THERE WERE NO CLINICAL CONSEQUENCES AS THE PRODUCT DID NOT REACH THE PATIENT, BUT THIS RESULTED IN A DELAY IN MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626086 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110042

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown