BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24G X 0.75IN (0.7 X 19 MM) ANGIOCATH

    MDR report key: 6753983 · Received July 31, 2017

    Report

    Report Number
    9610048-2017-00009
    Event Type
    Malfunction
    Date Received
    July 31, 2017
    Date of Event
    June 29, 2017
    Report Date
    September 21, 2017
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FOZ
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6180339. WERE RECEIVED PHOTOS OF THE CLAIMED PRODUCT (ATTACHED) AND AFTER ANALYSIS OF THE BD USA AND ACCORDING TO THE VISUAL ANALYSIS OF THESE PHOTOS, IT WAS POSSIBLE TO CONFIRM THE PRESENCE OF FOREIGN MATTER ON THE CATHETER. CONCLUSION: ACCORDING TO STUDIES AND PLANS TO REDUCE FOREIGN MATTER COMPLAINTS MADE BY (B)(4), IT CAN BE DETERMINED AFTER ANALYZING THE PHOTOS THAT THE MOST PROBABLE SOURCE FOR THIS TYPE OF FOREIGN MATTER MAY BE PRESENT DUE TO THE FOLLOWING SITUATION. WHEN THE CATHETER IS POINTED, THEY GET EXPOSED ON SHELVES THAT HAD NOT ALL THE PROTECTIONS, AND BECAUSE THEY ARE IN A PLACE OF PEOPLE PASS, IT WAS LIKELY THAT SOME AIRBORNE PARTICLES WOULD REACH THE CATHETER THAT HAS SILICONE ALONG ITS SURFACE, AS EVIDENCED DURING INTERNAL INVESTIGATIONS. WITHOUT THE ACTUAL SAMPLE AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    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 FOREIGN MATTER WAS FOUND ON THE CATHETER TIP OF A 24G X 0.75IN (0.7 X 19 MM) ANGIOCATH BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535553 24G X 0.75IN (0.7 X 19 MM) ANGIOCATH INTRAVASCULAR CATHETER FOZ BECTON DICKINSON IND. CIRURGICAS LTDA 6180339

    Patients

    Seq Age Sex Outcome Treatment
    1 Other