BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ IV CATHETER

    MDR report key: 8856357 · Received August 2, 2019

    Report

    Report Number
    8041187-2019-00602
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 11, 2019
    Report Date
    July 18, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SAMPLE WAS NOT DECONTAMINATED BY VENDOR. 4 PHOTOS AND 1 ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. CATHETER DAMAGE WAS OBSERVED IN THE RETURNED PHOTOS. CATHETER DAMAGE WAS OBSERVED FROM THE RETURNED SAMPLE. NO FOREIGN MATTER WAS OBSERVED FROM THE RETURNED SAMPLE. COMPLAINT HISTORY CHECK WAS PERFORMED ON REPORTED BATCH. DEVICE HISTORY RECORD OF PACKAGED NEEDLE (PN) BATCH 8170003 CATALOGUE NUMBER 388412 AND ITS ASSEMBLED NEEDLE (AN) BATCH 8171007 PART NUMBER 8301327 WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH. INVESTIGATION CONCLUSION: THE COMPLAINT IS CONFIRMED AND PRODUCT IS OUT OF SPECIFICATION CATHETER DAMAGED COULD HAVE BEEN CAUSED BY NEEDLE PIERCED THROUGH CATHETER. THIS COULD HAVE OCCURRED DURING ASSEMBLY OF CATHETER AND CANNULA OR DURING PRODUCT APPLICATION WHEN THE PRODUCT WAS MANIPULATED. THE BATCH PRODUCED IS BEFORE THE IMPLEMENTATION OF THE CAPA. CAPA HAD BEEN INITIATED TO ADDRESS NEEDLE PIERCED THROUGH CATHETER ISSUE. CAPA #: (B)(4). ROOT CAUSE DESCRIPTION: THIS SECTION IS NOT APPLICABLE AS THE REPORTED DEFECT IS A KNOWN ISSUE. REFER TO CAPA# (B)(4). RATIONALE: N.A.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ IV CATHETER HAD FOREIGN MATTER ON IT. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FM ON THE CATHETER. BDJ CONFIRMED THERE WAS A TRACE THAT CATHETER WAS PIERCED BY NEEDLE. CODE WAS CHANGED FROM FM TO NEEDLE THROUGH CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647813 BD INSYTE¿ IV CATHETER N/A FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8170003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other