BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10157856 · Received June 16, 2020

    Report

    Report Number
    3006948883-2020-00239
    Event Type
    Malfunction
    Date Received
    June 16, 2020
    Date of Event
    May 25, 2020
    Report Date
    August 24, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/3/2020. H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9233914. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THESE LOTS WERE ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. VISUAL EVALUATION OF THE RETURNED DEVICES ALLOWED BD ENGINEERS TO DETERMINE THE ROOT CAUSE FOR THIS EVENT WAS EXCESS ADHESIVE OBSTRUCTING THE FLUID PATH. DUE TO VARIABILITY IN THE MANUFACTURING PROCESS IT IS POSSIBLE FOR THE OVER-APPLICATION OF ADHESIVE TO OCCUR. PRESENTLY, BD USES IN-PROCESS INSPECTION STATIONS TO REMOVE ALL OBSERVED NON-CONFORMANCES PRIOR TO PACKAGING AND RELEASE OF EACH UNIT. IN RESPONSE TO THIS EVENT, BD HAS RETRAINED THE PACKAGING PERSONNEL TO PREVENT THE REOCCURRENCE OF THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAD A FAILED FLUSH. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS NO LIQUID FOUND AFTER THE INDWELLING NEEDLE WAS SUCCESSFULLY INJECTED , THE PATIENT WAS GIVEN A NEW NEEDLE AFTER THE TUBE WAS FAILED TO FLUSH WITH THE PRE-FILLED SYRINGE.

    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 HAD A FAILED FLUSH. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS NO LIQUID FOUND AFTER THE INDWELLING NEEDLE WAS SUCCESSFULLY INJECTED, THE PATIENT WAS GIVEN A NEW NEEDLE AFTER THE TUBE WAS FAILED TO FLUSH WITH THE PRE-FILLED SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624674 BD INTIMA-II CLOSED IV CATHETER SYSTEM CATHETER FPA BD (SUZHOU) 9233914

    Patients

    Seq Age Sex Outcome Treatment
    1 Other