BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 11129106 · Received January 7, 2021

    Report

    Report Number
    3006948883-2021-00029
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 2, 2020
    Report Date
    January 12, 2021
    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 0202485. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THEY DID NOT DISPLAY THE FAILURE MODE CLEARLY ENOUGH TO IDENTIFY THE ROOT CAUSE. UNFORTUNATELY, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT12; 00 , ON (B)(6) 2020, IN THE HALL, THE EMERGENCY RESCUE THE NURSE CHECK NEEDLE PACKING SOUND, IN THE PERIOD OF VALIDITY, ALL THE PARTS IN GOOD CONDITION, ACCORDING TO THE OPERATION PROCESS OF VEIN PUNCTURE, FOUND AFTER A SUCCESSFUL PUNCTURE NEEDLE Y TYPE TRANSPARENT TUBE HAS A ABOUT 2 MM GAP, IMMEDIATELY PULL OUT INDWELLING NEEDLE, TO CHILDREN WITH FAMILY MEMBERS TO DO A GOOD JOB OF EXPLAINING, AFTER THE REPLACEMENT OF INDWELLING NEEDLE PUNCTURE. AFTER SUCCESSFUL PUNCTURING, THERE WAS A 2MM CRACK BETWEEN THE Y-SHAPE JOINT OF THE INDWELLING NEEDLE AND THE EXTENSION TUBE. THE INDWELLING NEEDLE WAS PULLED OUT AND THE NEW PRODUCT WAS REPLACED. AFTER SUCCESSFUL PUNCTURE, BLOOD WILL BE COLLECTED THROUGH THE INDWELLING NEEDLE. AFTER SUCCESSFUL PUNCTURE, A 2MM GAP WAS FOUND. NO DAMAGE TO THE PRODUCT SURFACE.

    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 DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT12; 00 , ON (B)(6) 2020 , IN THE HALL, THE EMERGENCY RESCUE THE NURSE CHECK NEEDLE PACKING SOUND, IN THE PERIOD OF VALIDITY, ALL THE PARTS IN GOOD CONDITION, ACCORDING TO THE OPERATION PROCESS OF VEIN PUNCTURE, FOUND AFTER A SUCCESSFUL PUNCTURE NEEDLE Y TYPE TRANSPARENT TUBE HAS A ABOUT 2 MM GAP, IMMEDIATELY PULL OUT INDWELLING NEEDLE, TO CHILDREN WITH FAMILY MEMBERS TO DO A GOOD JOB OF EXPLAINING, AFTER THE REPLACEMENT OF INDWELLING NEEDLE PUNCTURE. AFTER SUCCESSFUL PUNCTURING, THERE WAS A 2MM CRACK BETWEEN THE Y-SHAPE JOINT OF THE INDWELLING NEEDLE AND THE EXTENSION TUBE. THE INDWELLING NEEDLE WAS PULLED OUT AND THE NEW PRODUCT WAS REPLACED. AFTER SUCCESSFUL PUNCTURE, BLOOD WILL BE COLLECTED THROUGH THE INDWELLING NEEDLE. AFTER SUCCESSFUL PUNCTURE, A 2MM GAP WAS FOUND. NO DAMAGE TO THE PRODUCT SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25785 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 0202485

    Patients

    Seq Age Sex Outcome Treatment
    1