BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 10007116 · Received April 28, 2020

    Report

    Report Number
    3006948883-2020-00153
    Event Type
    Malfunction
    Date Received
    April 28, 2020
    Date of Event
    April 7, 2020
    Report Date
    June 1, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9170827. 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 OUR REVIEW OF THE PROVIDED PHOTOGRAPH AND A REVIEW OF MAINTENANCE RECORDS, WHICH INDICATE WE HAVE BEEN ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS A TIMING ERROR IN THE REJECTION SYSTEM THAT MONITORS FINISH LUER-LOKS FOR DAMAGE. DUE TO THE TIMING ERROR THE AFFECTED UNIT WAS LIKELY DISTRIBUTED INTO THE WRONG BIN. TO ADDRESS THIS ISSUE OUR FACILITY HAS INSTALLED A COMPONENT TO THE AUTOMATED INSPECTION STATION THAT WILL ELIMINATE THE AFFECT UNITS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE PART OF THE CONNECTOR WAS DISCOVERED TO BE BROKEN WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE NURSE OPENED THE PACKAGE, SHE FOUND THAT A PART OF THE PLASTIC SHELL OF PRN AT THE CONNECTION BETWEEN THE HEPARIN CAP AND THE CONNECTOR WAS MISSING.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT PRIOR TO USE PART OF THE CONNECTOR WAS DISCOVERED TO BE BROKEN WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN THE NURSE OPENED THE PACKAGE, SHE FOUND THAT A PART OF THE PLASTIC SHELL OF PRN AT THE CONNECTION BETWEEN THE HEPARIN CAP AND THE CONNECTOR WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471729 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9170827

    Patients

    Seq Age Sex Outcome Treatment
    1 Other