BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC

    MDR report key: 10502733 · Received September 8, 2020

    Report

    Report Number
    3006948883-2020-00383
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 17, 2020
    Report Date
    September 14, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER: 0140318. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THEY DID NOT DISPLAY THE FAILURE MODE CLEARLY ENOUGH TO IDENTIFY THE ROOT CAUSE; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INTRAVENOUS PUNCTURE AND INFUSION, THE NEEDLE WAS INSERTED INTO ONE END OF THE HEPARIN CAP FOR INFUSION. IF NO INFUSION WAS CONDUCTED IN THE INFUSION JOINT, THE FRONT END OF THE INFUSION JOINT WAS SWAGED WITH FLUID.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INTRAVENOUS PUNCTURE AND INFUSION, THE NEEDLE WAS INSERTED INTO ONE END OF THE HEPARIN CAP FOR INFUSION. IF NO INFUSION WAS CONDUCTED IN THE INFUSION JOINT, THE FRONT END OF THE INFUSION JOINT WAS SWAGED WITH FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970113 INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC CATHETER FPA BD (SUZHOU) 0140318

    Patients

    Seq Age Sex Outcome Treatment
    1 Other