BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10613909 · Received October 1, 2020

    Report

    Report Number
    3006948883-2020-00452
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 4, 2020
    Report Date
    October 19, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9262111. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS 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 LEAKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT WAS WITH ACUTE BRONCHITIS ON (B)(6) 2020, PATIENT WENT TO HOSPITAL OUTPATIENT CLINIC, GIVEN INTRAVENOUS INFUSION THERAPY, AT 9:30 ON (B)(6) 2020, PATIENT WAS TO GIVE INTRAVENOUS PUNCTURE SUCCESS, ABOUT 9 PM ON (B)(6) 2020, 35 PATIENTS FEEL THE BACK OF THE HAND WITH LIQUID FLOW, CARE RIGHT AWAY TO SEE, FOUND THAT INFUSION NEEDLE AND JOINT LEAKAGE, FOUND NEEDLE JOINT CRACK, IMMEDIATELY STOP USING THE NEEDLE. THE PUNCTURE NEEDLE WAS REPLACED AND RE-PUNCTURED, BUT THE ABOVE SITUATION DID NOT OCCUR AGAIN.

    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 LEAKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT WAS WITH ACUTE BRONCHITIS ON (B)(6) 2020, PATIENT WENT TO HOSPITAL OUTPATIENT CLINIC, GIVEN INTRAVENOUS INFUSION THERAPY, AT 9:30 ON (B)(6) 2020, PATIENT WAS TO GIVE INTRAVENOUS PUNCTURE SUCCESS, ABOUT 9 PM ON (B)(6) 2020, 35 PATIENTS FEEL THE BACK OF THE HAND WITH LIQUID FLOW, CARE RIGHT AWAY TO SEE, FOUND THAT INFUSION NEEDLE AND JOINT LEAKAGE, FOUND NEEDLE JOINT CRACK, IMMEDIATELY STOP USING THE NEEDLE. THE PUNCTURE NEEDLE WAS REPLACED AND RE-PUNCTURED, BUT THE ABOVE SITUATION DID NOT OCCUR AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076101 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9262111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other