BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10242830 · Received July 7, 2020

    Report

    Report Number
    3006948883-2020-00279
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 16, 2020
    Report Date
    July 20, 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

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9023813. 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. BASED ON THE DESCRIPTION OF THE EVENT AND PREVIOUS INVESTIGATIONS INTO THIS PRODUCT FAMILY OUR ENGINEER SHAVE DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE PRESENCE OF SILICONE RESIDUE ON THE SLEEVE STOPPER. SILICONE IS USED IN THE MANUFACTURE OF THE INTIMA-II AND CAN REDUCE THE FRICTION IMPARTED ON THE SURFACE OF THE SLEEVE STOPPER. TO MONITOR OCCURRENCE SUCH AS THESE OUR TEAM IMPLEMENTS A PULL TEST TO CONFIRM THAT THE SLEEVE STOPPER IS PROPERLY FIXED INTO ITS POSITION; WE HAVE INCREASED THE FORCE REQUIREMENTS FOR THIS TEST AS WELL AS UPDATED OUR FINISHED GOODS INSPECTION LIST AND ADJUST TEMPERATURE SETTINGS ON THE HEAT TUNNELS TO INCREASE THE GRIP OF THE SLEEVE STOPPER. CAPA#1389644 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS EXPERIENCED PRN SEPARATION FROM THE ADAPTER PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE FEEDBACK FROM THE HEAD NURSE IN THE NEONATOLOGY DEPARTMENT OF THE FOREIGN USER FACILITY , ON THE MORNING OF 16 JUNE AT THE NEONATOLOGY WARD, THE RUBBER PLUG AND THE PLASTIC FIRM OF THE HEPARIN CAP FELL OFF DURING STERILIZING WITH THE BATCH NUMBER 9023813, AND THE ARTICLE NUMBER WAS 383083. THERE WERE TWO CASES OF THIS EVENT HAPPENED IN THE SAME DAY , THE HEAD NURSE IMMEDIATELY REMOVED THE INDWELLING NEEDLE AFTER THIS INCIDENT HAPPENED.

    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 2 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS EXPERIENCED PRN SEPARATION FROM THE ADAPTER PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE FEEDBACK FROM THE HEAD NURSE IN THE NEONATOLOGY DEPARTMENT OF THE FOREIGN USER FACILITY, ON THE MORNING OF 16 JUNE AT THE NEONATOLOGY WARD, THE RUBBER PLUG AND THE PLASTIC FIRM OF THE HEPARIN CAP FELL OFF DURING STERILIZING WITH THE BATCH NUMBER 9023813, AND THE ARTICLE NUMBER WAS 383083. THERE WERE TWO CASES OF THIS EVENT HAPPENED IN THE SAME DAY, THE HEAD NURSE IMMEDIATELY REMOVED THE INDWELLING NEEDLE AFTER THIS INCIDENT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707073 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 9023813

    Patients

    Seq Age Sex Outcome Treatment
    1 Other