BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 12913017 · Received December 1, 2021

    Report

    Report Number
    3003152976-2021-00791
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 1, 2021
    Report Date
    December 29, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE PICTURES RECEIVED IT CAN BE CONFIRMED LEAKAGE PAST THE STOPPER IN THE SYRINGE SHOWN. NO DAMAGE IN ANY OF THE VISIBLE PARTS OF THE SYRINGE CAN BE SEEN. STOPPER IS CORRECTLY ASSEMBLED IN THE DEVICE. TEN RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, NO DAMAGE CAN BE OBSERVED. STOPPER IS CORRECTLY IN ALL OF THE SYRINGES. FUNCTIONAL TEST WAS PERFORMED, NO LEAKAGE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2010110, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808126 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2010110

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown