BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7500550 · Received May 9, 2018

    Report

    Report Number
    9610048-2018-00053
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 17, 2018
    Report Date
    May 30, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811121
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLES/ PHOTOS: WERE RECEIVED TWO PHOTOS TO ANALYZE THE INCIDENT IN QUESTION. ACCORDING TO THE ANALYSIS OF THE PHOTOS IT WAS POSSIBLE TO VERIFY THE PRESENCE OF SILICONE DROPS ON THE CATHETER IN BOTH PHOTOS AND A SMALL BURR CAN BE SEEN AT THE TIP OF THE CANNULA. THE CONCLUSION OF THE INVESTIGATIONS OF THIS COMPLAINT DOES NOT REQUIRE THE PRESENCE OF PHYSICAL SAMPLES, THE PHOTOS THAT ARE ATTACHED ARE SUFFICIENT FOR THE DETERMINATION OF THE DEFECT, NOT ALTERING THE INVESTIGATION CARRIED OUT. DHR REVIEW: THE ASSEMBLY LOT: 6361823 PRODUCED IN 12/30/2017 THE 01/30/2017 AT ACAM # 01, USED IN THE CLAIMED FINAL PRODUCT LOT: 7010867 FROM ANGIOCATH 24G X 0.75IN WAS ANALYZED FOR THE TESTS TO VERIFY PRESENCE OF "FOREIGN MATTER / NO FOREIGN MATTER " AND WERE NOT SHOWN THIS DEFECT RECORDS IT WAS ANALYZED FOR NEEDLE TIP PENETRATION, CATHETER TIP AND CATHETER SLIP TESTS, AND NO RESULTS OF THESE TESTS WERE FOUND TO BE OUT OF SPECIFICATION. HOWEVER, RECORDS OF "KNEADING A CANNULA" AT STATION # 6, CHASSIS # 01 IN 01/25/2016 THE DEFECT EVIDENCED IN THE PHOTOS. QN/ NCMR REVIEW: NO RECORDS OF QUALITY NOTIFICATION OR REPORTS OF NON-CONFORMITY THAT COULD LEAD TO INCIDENTS IN TO THE LOTS INVOLVED IN THIS COMPLAINT WERE EVIDENCED. UNPLANNED MAINTENANCE: CORRECTIVE MAINTENANCE HISTORY WAS EVALUATED IN THE ASSEMBLY HISTORY OF THE LOT THE MAINTENANCE #601241092 WAS EVIDENCED DUE TO THE REASON: "KNEADING CANNULA¿; TRAIL #1, ACAM # 01, CHASSI #01" IN 01/25/2016. ACCORDING TO INVESTIGATIONS CARRIED OUT THIS MAINTENANCE CAN LEAD TO DAMAGE OBSERVED IN THE CANNULA. INVESTIGATION CONCLUSION: CONFIRMED: FOR THE CLAIMED DEFECTS FOREIGN MATTER AND NEEDLE BURR WERE CONFIRM THE INCIDENTS IN QUESTION. FOR THE DEFECT OF FOREIGN MATTER ACCORDING TO THE ATTACHED PHOTOS, IT CAN BE VERIFIED THAT IT IS SILICONE ON THE CATHETER. IT SHOULD BE NOTED THAT THIS SILICONE DOES NOT CAUSE DAMAGE TO THE WEARER AND IS USED TO AID IN THE SLIPPAGE OF THE CATHETER DURING VENIPUNCTURE. FOR GRINDING OF THE TIP OF THE CANNULA, ACCORDING TO THE ANALYSIS IN THE PHOTO, RESULT OF THE NEEDLE TIP, AND ANALYSIS OF THE BATCH HISTORY AND ANALYSIS OF CORRECTIVE MAINTENANCE HISTORY, WAS SUFFICIENT TO CONFIRM THE CUSTOMER'S COMPLAINT.

    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 FOREIGN MATTER, ONE DESCRIBED AS ¿GELATINOUS¿ AND ANOTHER DESCRIBED AS ¿ROUGH/BURR¿, WAS FOUND ON A BD ANGIOCATH¿ IV CATHETER. THE DEVICE WAS NOT USED AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343553 BD ANGIOCATH¿ IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7010867 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other