BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER SLIP¿ TUBERCULIN SYRINGE

    MDR report key: 7252924 · Received February 8, 2018

    Report

    Report Number
    8041187-2018-00021
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    January 15, 2018
    Report Date
    March 7, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    UDI-DI
    00382903096596
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE RETURNED UNIT AND CONFIRMED THE REPORTED OBSERVATION OF A BOWED SYRINGE BARREL. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. ONE PHOTO WAS RECEIVED FOR INVESTIGATION AND ONE ACTUAL SAMPLE WITHOUT PACKAGING WAS RETURNED FOR INVESTIGATION. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION AND OBSERVED THAT THE SYRINGE IS BENT AT NEAR 7ML TO 8ML MARKING. THE SAMPLE WAS SUBJECTED TO BARREL BOW MEASUREMENT AND FAILED THE SPECIFICATION. COMPLAINT HISTORY WAS REVIEWED. NO SIMILAR COMPLAINT WAS RECEIVED ON THE REPORTED NONCONFORMANCE. REVIEWED DEVICE HISTORY RECORD AND NO QUALITY NOTIFICATION WAS RAISED FOR THE REPORTED BATCH. PERFORMED MANUFACTURING REVIEW AND NO ABNORMALITY DETECTED. PROBABLE CAUSE COULD BE THE 1ML PRINTED BARREL WIP WAS BEING STACKED ON EACH OTHER, THIS COULD HAVE COMPRESSED THE BARREL RESULTING IN A BOW IN THE SYRINGE. THIS IS THE FIRST INCIDENT IN THE YEAR. WE WILL CONTINUE TO MONITOR THE REOCCURRENCE OF THIS NONCONFORMANCE. NO CAPA IS REQUIRED. OTHER CORRECTIVE ACTION WILL BE IMPLEMENTED. A COMMUNICATION TO THE TEAM NOT TO STACK THE 1ML PRINTED BARREL AND / OR MOLDED BARREL WIP ON EACH OTHER, AND ONLY PLACE THE PARTS ON THE TROLLEY.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    CORRECTION: CHANGED FROM : PMA/ 510K#: K1100774. CHANGED TO: PMA/ 510K#: K110771.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD LUER SLIP¿ TUBERCULIN SYRINGE PRODUCT BARREL WAS BOWED CAUSING VOLUMETRIC INACCURACY. FOUND BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101769 BD LUER SLIP¿ TUBERCULIN SYRINGE HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 6355418 00382903096596

    Patients

    Seq Age Sex Outcome Treatment
    1 Other