BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ

    MDR report key: 8965883 · Received September 5, 2019

    Report

    Report Number
    1911916-2019-00912
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    July 1, 2019
    Report Date
    October 4, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLES FOR THIS COMPLAINT WERE SENT BY THE CUSTOMER; HOWEVER, WE ARE UNABLE TO LOCATE THEM AT THIS TIME. SHOULD THEY BE LOCATED WE WILL RE-INVESTIGATE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THEREFORE, A POTENTIAL ROOT CAUSE(S) CANNOT BE DETERMINED, AND NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 22 SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INSPECTION OF BATCH NUMBER 8220711, SYRINGE 50 ML OF BD FROM USA, 22 SYRINGES FOUND WITH CLEARLY VISIBLE PARTICLES AND FLIEBERS. THERE WERE MANY MORE SYRINGES WITH PARTICLES BUT THEY WERE NOT BIG ENOUGH.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 22 SYRINGE 60 ML LL TIP 1 ML 2 OZ IN 1/4 OZ EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INSPECTION OF BATCH NUMBER 8220711, SYRINGE 50 ML OF BD FROM USA, 22 SYRINGES FOUND WITH CLEARLY VISIBLE PARTICLES AND FIBERS. THERE WERE MANY MORE SYRINGES WITH PARTICLES BUT THEY WERE NOT BIG ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761884 SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8220711 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other