BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 9781451 · Received March 3, 2020

    Report

    Report Number
    9610847-2020-00068
    Event Type
    Malfunction
    Date Received
    March 3, 2020
    Date of Event
    February 6, 2020
    Report Date
    March 23, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 7241750. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO FURTHER INVESTIGATE THIS ISSUE, ONE PHYSICAL SAMPLE AND ONE PICTURE SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE PHYSICAL SAMPLE WAS FUNCTIONALLY TESTED PER THE INSTRUCTIONS FOR USE AND NO DEFECTS WERE OBSERVED; THE PRODUCT WORKED AS INTENDED. NO FURTHER INVESTIGATIVE RESULTS COULD BE CONCLUDED FROM THE PROVIDED PICTURE SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY MECHANISM DISCONNECTED UPON RETRACTION WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE STYLET DISCONNECTED UPON RETRACTION FROM PATIENT WHICH EXPOSED THE NEEDLE. THE PATIENT AND STAFF MEMBER DID NOT RECEIVE A NEEDLE STICK INJURY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 THE SAFETY MECHANISM DISCONNECTED UPON RETRACTION WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE STYLET DISCONNECTED UPON RETRACTION FROM PATIENT WHICH EXPOSED THE NEEDLE. THE PATIENT AND STAFF MEMBER DID NOT RECEIVE A NEEDLE STICK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246560 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7241750

    Patients

    Seq Age Sex Outcome Treatment
    1 Other