BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 10788995 · Received November 4, 2020

    Report

    Report Number
    9610847-2020-00339
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    September 25, 2020
    Report Date
    December 2, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903056188
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED FINAL LOT NUMBER 0063788 AND ALL APPLICABLE SUB-ASSEMBLY LOT NUMBERS. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, LEAKAGE WAS OBSERVED PAST THE SECOND RIB OF THE STOPPER COMPONENT IN ONE PICTURE. IN THE REMAINING TWO PICTURES, LIQUID WAS OBSERVED PAST THE FIRST STOPPER RIB. AN EXACT MANUFACTURING RELATED CAUSE HAS NOT BEEN DETERMINED FOR THIS INCIDENT AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE LEAKED PAST THE STOPPER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MULTIPLE SYRINGES FILLED WITH FINISHED PRODUCT WERE OBSERVED TO HAVE FLUID ON THE PLUNGER TIP RIBS AND PAST THE BASE OF THE PLUNGER TIP. SYRINGES ARE FILLED WITH CONTROLLED SUBSTANCE."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE LEAKED PAST THE STOPPER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MULTIPLE SYRINGES FILLED WITH FINISHED PRODUCT WERE OBSERVED TO HAVE FLUID ON THE PLUNGER TIP RIBS, AND PAST THE BASE OF THE PLUNGER TIP. SYRINGES ARE FILLED WITH CONTROLLED SUBSTANCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251186 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 305618 0063788 30382903056188

    Patients

    Seq Age Sex Outcome Treatment
    1