BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PERISAFE I¿

    MDR report key: 7990873 · Received October 22, 2018

    Report

    Report Number
    9610847-2018-00344
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    September 21, 2018
    Report Date
    November 14, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    CAZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DHR FOR LOT NUMBER 8030608 WAS REVIEWED AND NO QNS OR OTHER EVENTS WERE RELATED TO THE COMPLAINT STATED BY THE CUSTOMER. MATERIAL (B)(4) WITH LOT NUMBER 8030608 WAS MANUFACTURED ON JANUARY 31, 2018. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED. DURING THIS LOT, 20 SAMPLES WERE TESTED BY LEAK TEST AND FUNCTIONALITY ON THE LUER MOLD OF THE NEEDLE WEISS EPIDURAL. THIS TEST IS PERFORMED BY QA TECH ON FINAL INSPECTION OF THE KIT, DURING THIS TEST NO VALUES OUT OF SPECIFICATION OR HOLE WERE FOUND. THE NEEDLE WEISS EPIDURAL IT IS A SUBASSEMBLY THAT IS PLACED IN THE KIT. DURING THE PACKAGING OF THIS LOT, WAS USED THE LOT NUMBER 8008594 OF THE NEEDLE SUBASSEMBLY, THIS LOT WAS MANUFACTURED ON JANUARY 09, 2018. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ALSO ACCEPTED. DURING THE MANUFACTURE OF SUBASSEMBLY OF LOT 8008594, 258 SAMPLES WERE TESTED FOR LEAK TEST ON THE LUER MOLD OF THE NEEDLE WEISS EPIDURAL. THIS TEST IS PERFORMED BY QA TECH ON MOLDING PROCESS OF THE NEEDLE, DURING THIS TEST NO VALUES OUT OF SPECIFICATION OR HOLE WERE FOUND. ALL RELEVANT INFORMATION DURING THE DHR REVIEW SHOWN THAT MEET ALL ESTABLISHED MANUFACTURING CRITERIA. NO SAMPLE WAS PROVIDED TO PERFORM THE TESTING AND INVESTIGATION OF THE COMPLAINT MADE BY THE CUSTOMER. ON THE PHOTOS PROVIDED IT IS NOT SHOWN CLEARLY THE DEFECT STATED BY THE CUSTOMER THAT IS WHY WE COULD NOT CONFIRM THE DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PERISAFE I HAD A HOLE IN THE NEEDLE CHAMBER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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 A BD PERISAFE I¿ HAD A HOLE IN THE NEEDLE CHAMBER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831343 BD PERISAFE I¿ EPIDURAL CATHETER KIT CAZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8030608

    Patients

    Seq Age Sex Outcome Treatment
    1 Other