BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL TIP CONV PAK

    MDR report key: 8945397 · Received August 29, 2019

    Report

    Report Number
    9610847-2019-00544
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 12, 2019
    Report Date
    October 3, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903056171
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9060761. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. AFTER A REVIEW OF THE SAMPLES SUBMITTED AND THE EVENT DESCRIPTION OUR ENGINEERS DETERMINED THAT THE ROOT CASE WAS DUE TO BD SYRINGES BEING DESIGNED TO BE USED AS SOON AS POSSIBLE AFTER THEY ARE REMOVED FROM THEIR ORIGINAL CONTAINERS. BD SYRINGES ARE NOT DESIGNED TO STORE MEDICATION, AND SHOULD NOT BE USED IN THIS MANNER TO DISTRIBUTE MEDICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON THE BOTTOM OF THE SYRINGE WITH A BD SYRINGE 20ML LL TIP CONV PAK. THIS OCCURRED ON 10 SEPARATE OCCASIONS DURING, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 20 ML SYRINGE HAD A WHITE POWDER AT THE BOTTOM OF THE SYRINGE.

    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 THERE WAS FOREIGN MATTER ON THE BOTTOM OF THE SYRINGE WITH A BD SYRINGE 20ML LL TIP CONV PAK. THIS OCCURRED ON 10 SEPARATE OCCASIONS DURING, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 20 ML SYRINGE HAD A WHITE POWDER AT THE BOTTOM OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741751 BD SYRINGE 20ML LL TIP CONV PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9060761 30382903056171

    Patients

    Seq Age Sex Outcome Treatment
    1 Other