BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 8203317 · Received December 28, 2018

    Report

    Report Number
    8041187-2018-00497
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 12, 2018
    Report Date
    January 11, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    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: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8173316 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 WITH THE USE OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH EXTENSION TUBE BROKEN.

    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 WITH THE USE OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH EXTENSION TUBE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044120 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8173316

    Patients

    Seq Age Sex Outcome Treatment
    1 Other