BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10774967 · Received November 2, 2020

    Report

    Report Number
    3006948883-2020-00672
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    September 8, 2020
    Report Date
    November 23, 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

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9170843. 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. ADDITIONALLY, A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING, BUT THIS LOT WAS TREATED AND RECEIVED A CERTIFICATE OF CONFORMANCE FOR STERILITY. UNFORTUNATELY, WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED CATHETER DAMAGE/DEFORMATION AND CATHETER SPLITTING/FRAYING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO HOSPITAL ON SEPTEMBER 8 FOR TREATMENT OF BRONCHOPNEUMONIA BY INTRAVENOUS INFUSION. INDWRESTING NEEDLE WAS USED TO FACILITATE FLUID INPUT AND RELIEVE THE PAIN OF DAILY INJECTION. HALF AN HOUR AFTER INSERTION, THE INFUSION SITE OF THE CHILD WAS SWOLLEN, PAINFUL AND CRYING. THE PLASTIC INDWELLING PART OF THE SPLIT WAS FOUND WHEN THE INDWELLING NEEDLE WAS PULLED OUT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED CATHETER DAMAGE/DEFORMATION AND CATHETER SPLITTING/FRAYING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO HOSPITAL ON SEPTEMBER 8 FOR TREATMENT OF BRONCHOPNEUMONIA BY INTRAVENOUS INFUSION. IN WRESTING NEEDLE WAS USED TO FACILITATE FLUID INPUT AND RELIEVE THE PAIN OF DAILY INJECTION. HALF AN HOUR AFTER INSERTION, THE INFUSION SITE OF THE CHILD WAS SWOLLEN, PAINFUL AND CRYING. THE PLASTIC INDWELLING PART OF THE SPLIT WAS FOUND WHEN THE INDWELLING NEEDLE WAS PULLED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234302 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 9170843

    Patients

    Seq Age Sex Outcome Treatment
    1