BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN.

    MDR report key: 6993563 · Received November 1, 2017

    Report

    Report Number
    9610048-2017-00059
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    August 28, 2017
    Report Date
    December 7, 2017
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR QUALITY ENGINEER WAS ABLE TO CONFIRM THE REPORTED COMPLAINT AFTER ANALYSIS OF THE CLAIMED PRODUCT. ASSEMBLED LOT: 7087506, USED IN THE CLAIMED FINAL PRODUCT LOT: 7122589 OF INSYTE AUTOGUARD 22G X 1.00 WAS ANALYZED FOR "NEEDLE RETRACTION" AND ¿PART ACTIVATION¿ TESTS, AND IT WAS EVIDENCED FAILURE IN THE ACTIVATION OF THE PART DURING THE PERFORMING OF THIS TEST. THE ROOT CAUSE WAS DETERMINED TO BE THE PLUG PLACEMENT STATION 5.54.4 DURING ASSEMBLY OF THE PRODUCT. BD WAS ABLE TO CONFIRM THE INCIDENT IN QUESTION. AFTER ANALYSIS OF THE QN/NCMR OF THE CLAIMED PRODUCT, IT WAS POSSIBLE TO CONFIRM THE COMPLAINT OF THE NEEDLE RETRACTION FAILURE. SAMPLES OR PHOTOS HAVE NOT RECEIVED FOR ANALYSIS OF THE INCIDENT IN QUESTION. DHR/QN/NCMR REVIEW: ASSEMBLED LOT: 7087506, USED IN THE CLAIMED FINAL PRODUCT LOT: 7122589 OF INSYTE AUTOGUARD 22G X 1.00 WAS ANALYZED FOR "NEEDLE RETRACTION" AND ¿PART ACTIVATION¿ TESTS, AND IT WAS EVIDENCED FAILURE IN THE ACTIVATION OF THE PART DURING THE PERFORMING OF THIS TEST. QN/NCMR REVIEW: IT WAS EVIDENCED QUALITY NOTIFICATION (QN) # (B)(4) FOR THE DEFECT ¿PART ACTIVATION FAILED¿, WHICH INVOLVES THE ASSEMBLY LOT: 7087506. BASED ON THE INVESTIGATIONS, THE ROOT CAUSE OF QUALITY NOTIFICATION # (B)(4) EVIDENCED A FAILURE OCCURRED AT THE PLUG PLACEMENT STATION 5.54.4 DURING ASSEMBLY OF THE PRODUCT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE ON A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN. WAS EXPOSED AFTER THE SAFETY WAS ACTIVATED. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774349 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN. INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7122589 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other