BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II IV CATHETER

    MDR report key: 16907175 · Received May 10, 2023

    Report

    Report Number
    3014704491-2023-00180
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    February 21, 2023
    Report Date
    May 12, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2172312. 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 H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II IV CATHETER EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6), 2023, BEFORE USING THE INDWELLING NEEDLE TO PERFORM VENIPUNCTURE ON THE CHILD, THE INDWELLING NEEDLE WAS PRE-FLUSHED WITH NORMAL SALINE, AND IT WAS FOUND THAT THE HEPARIN WAS LEAKING. AFTER TIGHTENING THE HEPARIN CAP, IT STILL LEAKED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II IV CATHETER EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023, BEFORE USING THE INDWELLING NEEDLE TO PERFORM VENIPUNCTURE ON THE CHILD, THE INDWELLING NEEDLE WAS PRE-FLUSHED WITH NORMAL SALINE, AND IT WAS FOUND THAT THE HEPARIN WAS LEAKING. AFTER TIGHTENING THE HEPARIN CAP, IT STILL LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231524 BD INTIMA-II IV CATHETER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2172312

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown