BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 16747795 · Received April 14, 2023

    Report

    Report Number
    9610847-2023-00088
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 19, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833283
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THE DETACHABLE SAFETY SYSTEM DISENGAGED FROM THE NEEDLE LEAVING THE NEEDLE FREE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE COMPLETED. TO AID IN THE INVESTIGATION, ONE PICTURE WAS RECEIVED FOR ANALYSIS BY OUR QUALITY TEAM. THE PHOTO SHOWS THE SAFETY DEVICE WAS NOT COVERING THE NEEDLE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 383328, LOT 2032682. THE REVIEW REVEALED THERE WERE NO INTERNAL REJECTS RELATED TO THE REPORTED ISSUE BY THE CUSTOMER. ACCORDING TO THE QUALITY RECORDS ALL THE INSPECTIONS OF THE SAMPLING PLAN MET THE ACCEPTANCE CRITERIA. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION RESULTS, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM THE SAFETY MECHANISM DETACHED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WHEN PLACING THE CATHETER SUBCUTANEOUSLY IN ONE PATIENT, WHEN REMOVING THE NEEDLE, THE DETACHABLE SAFETY SYSTEM DISENGAGED FROM THE NEEDLE LEAVING THE NEEDLE FREE. THERE WAS NO NEED TO CHANGE THE PATIENT'S CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM THE SAFETY MECHANISM DETACHED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WHEN PLACING THE CATHETER SUBCUTANEOUSLY IN ONE PATIENT, WHEN REMOVING THE NEEDLE, THE DETACHABLE SAFETY SYSTEM DISENGAGED FROM THE NEEDLE LEAVING THE NEEDLE FREE. THERE WAS NO NEED TO CHANGE THE PATIENT'S CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819093 BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2032682 00382903833283

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown