BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN

    MDR report key: 11312178 · Received February 11, 2021

    Report

    Report Number
    9610847-2021-00066
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 19, 2021
    Report Date
    March 25, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833467
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A COMPLAINT OF A CATHETER BREAKING AFTER PLACEMENT WAS RECEIVED FROM THE CUSTOMER. A SAMPLE WAS PROVIDED TO AID IN THE INVESTIGATION OF THIS DEFECT. THROUGH VISUAL INSPECTION THE CUSTOMER COMPLAINT WAS CONFIRMED. DURING INVESTIGATION IT WAS FOUND THAT THE TUBING HAD AN INSUFFICIENT AMOUNT OF SOLVENT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 9122995. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. THE ROOT CAUSE FOR THIS DEFECT WAS DETERMINED TO BE AN INSUFFICIENT AMOUNT OF SOLVENT ADDED DURING MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN NEEDLE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE WAS PERFORMED PUNCTURING FOR THE PATIENT, DURING PROCESS TO DELIEVE THE NEEDLE, IT WAS FOUND THAT NEEDLE WAS SUDDENLY BROKEN WHEN IT WAS WITHDRAWN WITH 2 MM, THE NURSE HEARD A RELATIVELY CRISP SOUND, CUSTOMER SUSPECTED THAT THERE WAS A PROBLEM WITH THE QUALITY BEFORE THE PUNCTURING.

    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 SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN NEEDLE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE WAS PERFORMED PUNCTURING FOR THE PATIENT, DURING PROCESS TO DELIEVE THE NEEDLE, IT WAS FOUND THAT NEEDLE WAS SUDDENLY BROKEN WHEN IT WAS WITHDRAWN WITH 2 MM, THE NURSE HEARD A RELATIVELY CRISP SOUND, CUSTOMER SUSPECTED THAT THERE WAS A PROBLEM WITH THE QUALITY BEFORE THE PUNCTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214087 SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9122995 00382903833467

    Patients

    Seq Age Sex Outcome Treatment
    1