BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA II¿ IV CATHETER

    MDR report key: 7437209 · Received April 17, 2018

    Report

    Report Number
    3006948883-2018-00055
    Event Type
    Injury
    Date Received
    April 17, 2018
    Date of Event
    April 10, 2018
    Report Date
    May 22, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K100775
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A REPRESENTATIVE SAMPLE AND A PHOTO WERE RECEIVED FOR THE PURPOSE OF INVESTIGATION. THE INVESTIGATORS WERE ABLE TO OBSERVE THE REPORTED FAILURE MODE IN THE SAMPLE PROVIDED. THE BATCH RECORD WAS REVIEWED, NO RELATED ABNORMALITIES WERE FOUND. INVESTIGATION CONCLUSION: CONFIRMED. BD WAS ABLE TO CONFIRM THE REPORTED ISSUE. ACCORDING TO THE COMPLAINT INFORMATION THE CATHETER WAS PLACED AND FUNCTIONING NORMALLY FOR TWO DAYS PRIOR TO FAILURE SUGGESTING THAT THE UNIT MAY HAVE BEEN ACTED ON BY AN EXTERNAL FORCE, CAUSING THE REPORTED ISSUE. UNFORTUNATELY BECAUSE THE AFFECTED UNIT WAS NOT RETURNED THE ROOT CAUSE FOR THIS ISSUE COULD NOT BE FINALIZED, HOWEVER BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7265045, EXPIRATION DATE: 2020-11-11, MANUFACTURE DATE: 2017-09-22. MEDICAL DEVICE LOT #: 7142043, EXPIRATION DATE: 2020-06-23, MANUFACTURE DATE: 2017-05-22. MEDICAL DEVICE LOT #: 8032238, EXPIRATION DATE: 2021-01-18, MANUFACTURE DATE: 2018-02-01. 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 DURING USE OF THE BD INTIMA II¿ IV CATHETER THERE WAS AN ISSUE WITH A BROKEN CATHETER. THE CUSTOMER STATED ¿WHEN THE NURSE PREPARED FOR INFUSION AND FLUSH THE NURSE FOUND WATER EXUDATE FROM CATHETER APPLICATION. THE NURSE REMOVED THE APPLICATION AND FOUND CATHETER BROKEN. THE PATIENT WAS SCANNED AND FOUND BLURRED IMAGE IN THE 1/3 RIGHT- ARM OF PATIENT. THE PATIENT WAS TRANSFERRED TO SHANXI OTHER HOSPITAL TO FIND THE BROKEN PART. CT SCANNED ON THE PATIENT AND NO FOREIGN MATTER WAS DETECTED ON (B)(6) 2018.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281091 BD INTIMA II¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention