BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 8214000 · Received January 3, 2019

    Report

    Report Number
    3006948883-2018-00336
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 14, 2018
    Report Date
    January 11, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8171389 OUR RECORDS DETERMINED THAT THIS IS THE ONLY INSTANCE OF A NEEDLE BENT 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. INVESTIGATION CONCLUSION: WITH THE SAMPLE PROVIDED, OUR ENGINEERS ATTEMPTED TO REPLICATE THE DAMAGE OBSERVED IN THE DEVICE, THROUGH THE REPEATED APPLICATION OF THE PINCH CLAMP. OUR TESTING WAS CONCLUDED AFTER 30 ATTEMPTS, WITH NO OBSERVABLE DAMAGE OCCURRING TO THE TUBING. ROOT CAUSE DESCRIPTION: BASED ON THESE RESULTS, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW. RATIONALE: BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM EXTENSION TUBING WAS DAMAGED AND LEAKED.

    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 THE BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM EXTENSION TUBING WAS DAMAGED AND LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5675 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8171389

    Patients

    Seq Age Sex Outcome Treatment
    1 Other