BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 8623907 · Received May 20, 2019

    Report

    Report Number
    9610048-2019-00184
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    March 4, 2019
    Report Date
    June 6, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811237
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD WAS UNABLE TO VERIFY THERE WAS ANY CATHETER DEFECT. HOWEVER, WHEN THE OPENED SAMPLE ARRIVED THERE WAS NOTED TO BE SILICONE AND A THREAD ON THE CATHETER. FOURIER-TRANSFORM INFRARED SPECTROSCOPY TESTING FOUND THE THREAD WAS MOST LIKELY A COMBINATION OF INDIGO AND CELLULOSE (DENIM FOR BLUE JEANS) AND SILICONE. IT SHOULD BE NOTED THAT THIS SILICONE DOES NOT CAUSE DAMAGE TO THE USER AND IS USED TO AID IN THE SLIPPAGE OF THE CATHETER DURING VENIPUNCTURE. THE ROOT CAUSE OF THIS ISSUE ON THE CATHETER IS CAUSED BY THE EXCESSIVE AMOUNT OF SILICONE THAT IS DISPENSED DURING THE SILICONIZATION OF THE CATHETER TIP TIPPING AND FINAL ASSEMBLY PROCESS, FOR THE DARK THREAD FOUND IN THE CATHETER IT MAY HAVE COME LOOSE OCCASIONALLY AND HAVE JOINED IN THE ASSEMBLY PROCESS DUE TO THE EXCESS OF THE SILICONE. A CORRECTIVE ACTION PROJECT, CAPA#45094, HAS BEEN INITIATED TO INVESTIGATE THE ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY# 004713BJF LOT 7241709 MANUFACTURED FROM 30-AUG-17 TO 29-SEP-17 IN ACAM03 MACHINE USED IN CLAIMED LOT 7247585. THE BATCH WAS ANALYZED FOR ¿DAMAGED COMPONENT¿, ¿FOREIGN MATTER¿ AND WERE NOT EVIDENCED RECORDS THAT COULD LEAD TO THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ANGIOCATH¿ IV CATHETER HAS SMALL SILICONE DROPLETS AND FOREIGN MATTER ON THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USING, IT WAS FOUND THE CATHETER IS ROUGH AND BURR, WHICH IS NOT CONDUCIVE TO PUNCTURE. ADDITIONAL INFORMATION: I VISUALLY INSPECTED THE RETURNED SAMPLE AND DID NOT FIND ANY DAMAGE TO THE NEEDLE OR CATHETER. HOWEVER, THERE IS SOME SMALL SILICONE DROPLETS AND FOREIGN MATTER ON THE CATHETER.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ANGIOCATH¿ IV CATHETER HAS SMALL SILICONE DROPLETS AND FOREIGN MATTER ON THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USING, IT WAS FOUND THE CATHETER IS ROUGH AND BURR, WHICH IS NOT CONDUCIVE TO PUNCTURE. ADDITIONAL INFORMATION: I VISUALLY INSPECTED THE RETURNED SAMPLE AND DID NOT FIND ANY DAMAGE TO THE NEEDLE OR CATHETER. HOWEVER, THERE IS SOME SMALL SILICONE DROPLETS AND FOREIGN MATTER ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416262 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7247585 30382903811237

    Patients

    Seq Age Sex Outcome Treatment
    1 Other