BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10168859 · Received June 18, 2020

    Report

    Report Number
    3006948883-2020-00244
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 27, 2020
    Report Date
    July 27, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9233906. 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. ALTHOUGH A PHOTOGRAPH WAS SUBMITTED DISPLAYING THE BROKEN CATHETER, GIVEN THE NATURE OF THE REPORTED FAILURE MODE THE ROOT CAUSE COULD NOT DETERMINED FROM THE ANGEL PROVIDED. IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT. THE UNITS WERE PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS BROKEN. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE NURSE'S INFUSION, THE ROOT PART OF THE CATHETER WAS BROKEN, AND THE BROKEN PART WAS NOT PUNCTURED INTO THE PATIENT'S BODY. A NEW INDWELLING NEEDLE WAS REPLACED, IT DID NOT CAUSE ANY INJURY TEMPORARILY. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 2020-06-02: THE CATHETER HAS NO RESIDUE IN THE PATIENT. THE ENTIRE CATHETER WAS BROKEN AND STUCK TO THE DRESSING. NO CATHETER REMAINS ON THE CATHETER HUB.

    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 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS BROKEN. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE NURSE'S INFUSION, THE ROOT PART OF THE CATHETER WAS BROKEN, AND THE BROKEN PART WAS NOT PUNCTURED INTO THE PATIENT'S BODY. A NEW INDWELLING NEEDLE WAS REPLACED, IT DID NOT CAUSE ANY INJURY TEMPORARILY. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 2020-06-02: THE CATHETER HAS NO RESIDUE IN THE PATIENT. THE ENTIRE CATHETER WAS BROKEN AND STUCK TO THE DRESSING. NO CATHETER REMAINS ON THE CATHETER HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635909 BD INTIMA-II CLOSED IV CATHETER SYSTEM CATHETER FPA BD (SUZHOU) 9233906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other