BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    MDR report key: 11312244 · Received February 11, 2021

    Report

    Report Number
    9610847-2021-00069
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 9, 2021
    Report Date
    March 25, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833123
    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

    INVESTIGATION SUMMARY: A COMPLAINT OF FOREIGN MATTER WAS RECEIVED FROM THE CUSTOMER. A SAMPLE AND PHOTO WERE PROVIDED TO AID IN THE INVESTIGATION OF THIS DEFECT. THE CUSTOMER COMPLAINT WAS CONFIRMED DURING INSPECTION OF THE PROVIDED PHOTO. WHEN THE SAMPLE WAS BEING INSPECTED, THE FOREIGN MATTER COULD NOT BE FOUND. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 9122982. 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. DUE TO THE FOREIGN MATTER SEEN IN THE PHOTO, BUT NOT BEING ABLE TO BE ANALYZED ON THE SAMPLE, A ROOT CAUSE COULD NOT BE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD HAIR-LIKE FOREIGN MATTER ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "CUSTOMER FOUND THERE WAS HAIR SIMILAR FOREIGN MATTER ON THE NEEDLE AFTER REMOVED THE NEEDLE SHIELD, CUSTOMER DIDN'T USE THIS NEEDLE".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD HAIR-LIKE FOREIGN MATTER ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "CUSTOMER FOUND THERE WAS HAIR SIMILAR FOREIGN MATTER ON THE NEEDLE AFTER REMOVED THE NEEDLE SHIELD, CUSTOMER DIDN'T USE THIS NEEDLE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210418 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383312 9122982 30382903833123

    Patients

    Seq Age Sex Outcome Treatment
    1