BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA¿-II IV CATHETER

    MDR report key: 17166944 · Received June 20, 2023

    Report

    Report Number
    3014704491-2023-00268
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    May 5, 2023
    Report Date
    June 25, 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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2172286. 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 H10.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT DURING USE WITH BD INTIMA¿-II IV CATHETER THE NEEDLE DETACHED. PATIENT WAS RE-PUNCTURED AND THERE WAS NO ADDITIONAL IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PREGNANT WOMAN GAVE BIRTH IN OUR HOSPITAL ON (B)(6) 2023. DURING THE INFUSION TREATMENT, IT WAS FOUND THAT THE NEEDLE OF THE INDWELLING NEEDLE CAME OUT OF THE NEEDLE CAP. AFTER THE DISCOVERY, IT WAS REPLACED IMMEDIATELY AND RE-PUNCTURED, AND NO ADVERSE REACTIONS WERE CAUSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD INTIMA¿-II IV CATHETER THE NEEDLE DETACHED. PATIENT WAS RE-PUNCTURED AND THERE WAS NO ADDITIONAL IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PREGNANT WOMAN GAVE BIRTH IN OUR HOSPITAL ON (B)(6) 2023. DURING THE INFUSION TREATMENT, IT WAS FOUND THAT THE NEEDLE OF THE INDWELLING NEEDLE CAME OUT OF THE NEEDLE CAP. AFTER THE DISCOVERY, IT WAS REPLACED IMMEDIATELY AND RE-PUNCTURED, AND NO ADVERSE REACTIONS WERE CAUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525753 BD INTIMA¿-II IV CATHETER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2172286

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown