BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA SAFETY SYSTEM WITH REMOVABLE PRN 24 GA 0.75 IN

    MDR report key: 11702535 · Received April 21, 2021

    Report

    Report Number
    9610847-2021-00175
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 1, 2021
    Report Date
    May 3, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833123
    PMA / PMN Number
    K923702
    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 9031833. 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. UNFORTUNATELY, A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. 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 BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 24 GA 0.75 IN HAD A NEEDLE THROUGH THE CATHETER. "AT 14:00 ON (B)(6) 2021, THE PATIENT UNDERWENT VENIPUNCTURE WITH A CLOSED INDWELLING NEEDLE WITH AUTOMATIC RETRACTING TIP AS INSTRUCTED BY THE DOCTOR. WHEN THE NEEDLE WAS WITHDRAWN, THE NEEDLE WAS FOUND TO PROTRACT FROM THE SIDE OF THE CATHETER TUBE AND BLOOD FLOWED SPONTANEOUSLY FROM THE DAMAGED AREA. THE PATIENT WAS REPLACED WITH A NEW NEEDLE AND THE PUNCTURING WAS SUCCESSFUL. ADR# 111232200202100075".

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SAF-T-INTIMA" SAFETY SYSTEM WITH REMOVABLE PRN 24 GA 0.75 IN HAD A NEEDLE THROUGH THE CATHETER. "AT 14:00 ON (B)(6) 2021, THE PATIENT UNDERWENT VENIPUNCTURE WITH A CLOSED INDWELLING NEEDLE WITH AUTOMATIC RETRACTING TIP AS INSTRUCTED BY THE DOCTOR. WHEN THE NEEDLE WAS WITHDRAWN, THE NEEDLE WAS FOUND TO PROTRACT FROM THE SIDE OF THE CATHETER TUBE AND BLOOD FLOWED SPONTANEOUSLY FROM THE DAMAGED AREA. THE PATIENT WAS REPLACED WITH A NEW NEEDLE AND THE PUNCTURING WAS SUCCESSFUL. ADR# (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599956 BD SAF-T-INTIMA SAFETY SYSTEM WITH REMOVABLE PRN 24 GA 0.75 IN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383312 9031833 30382903833123

    Patients

    Seq Age Sex Outcome Treatment
    1