BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML SYRINGE CONCENTRIC LUER LOCK

    MDR report key: 12921686 · Received December 2, 2021

    Report

    Report Number
    3003152976-2021-00796
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 4, 2021
    Report Date
    January 11, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION IT CAN BE SEEN THE 50LL SYRINGE SHOWING LEAKAGE PAST THE STOPPER. NO DAMAGE IN THE BARREL IS OBSERVED AND STOPPER IN THE PICTURE IS CORRECTLY ASSEMBLED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2012070 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, UPON VISUAL INSPECTION NO DAMAGE CAN BE OBSERVED IN ANY OF THE INDIVIDUAL PARTS. STOPPER IS CORRECTLY ASSEMBLED IN THE TEN SYRINGES. ONCE FUNCTIONAL TEST IS PERFORMED, THESE SYRINGES WERE DISASSEMBLED FINDING NO DAMAGE IN THE PLUNGER THAT COULD LEAD TO THE LEAKAGE EXPERIENCED BY CUSTOMER. ADDITIONALLY, LEAKAGE TEST WAS PERFORMED AND NO DEFECTS OR LEAK 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. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK 50ML SYRINGE CONCENTRIC LUER LOCK HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE FAILURE ISSUE WITH ONE OF THE 50ML SYRINGES WE USE, SAME THING HAPPENED WITH ANOTHER ONE A FEW MONTHS BACK, PLANS ARE TO JUST KEEP AN EYE ON IT AT THE MOMENT AS WE USE HEAPS OF THE 50ML SYRINGES AND THIS IS ONLY THE SECOND ISSUE TO BE REPORTED, IF IT STARTS BECOMING MORE FREQUENT THEN I SUSPECT THE ANAESTHETISTS WILL WANT THE SYRINGES CHANGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK 50ML SYRINGE CONCENTRIC LUER LOCK HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE FAILURE ISSUE WITH ONE OF THE 50ML SYRINGES WE USE, SAME THING HAPPENED WITH ANOTHER ONE A FEW MONTHS BACK, PLANS ARE TO JUST KEEP AN EYE ON IT AT THE MOMENT AS WE USE HEAPS OF THE 50ML SYRINGES AND THIS IS ONLY THE SECOND ISSUE TO BE REPORTED, IF IT STARTS BECOMING MORE FREQUENT THEN I SUSPECT THE ANAESTHETISTS WILL WANT THE SYRINGES CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817877 BD PLASTIPAK 50ML SYRINGE CONCENTRIC LUER LOCK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 309653 2012070 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown