BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7060600 · Received November 27, 2017

    Report

    Report Number
    9610048-2017-00072
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 20, 2017
    Report Date
    December 28, 2017
    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
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    CONFIRMED: BD WAS ABLE TO CONFIRM/ REPRODUCE THE INCIDENT IN QUESTION. INVESTIGATION COMMENTS: AFTER ANALYZING THE PHOTO RETURNED FROM THE CLIENT, IT WAS POSSIBLE TO CONFIRM THE PRESENCE OF DROPLETS OF 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. SAMPLES/PHOTOS: ACCORDING TO VISUAL ANALYSIS OF PHOTO HK-18017 IT WAS POSSIBLE TO VERIFY THE PRESENCE OF DROPLETS OF SILICONE ON THE CATHETER DHR/QN/NCMR REVIEW: FINAL ASSEMBLY LOTS: 6152234SH, 6179393 RESPECTIVELY USED IN THE CLAIMED FINAL PRODUCT BATCH: 6180339 OF ANGIOCATH YEL 24GA X 0.75IN WAS TESTED FOR PRESENCE OF "FOREIGN/NO FOREIGN MATTER" AND NO RECORDS OF THIS DEFECT WERE FOUND.QN/ NCMR REVIEW: THERE ARE NO RECORDS OF QUALITY NOTIFICATION (QN) OR NON-CONFORMANCE REPORT (RNC) OF FOREIGN MATTER, FOR THE LOT INVOLVED IN THIS CLAIM, ACCORDING TO THE HISTORY OF THE LOT ABOVE. BASED ON THE INVESTIGATIONS CONDUCTED FOR CLAIMS OF EXCESS SILICONE OF ANGIOCATH, IT HAS BEEN FOUND THAT THE ROOT CAUSE OF THIS ON THE CATHETER IS CAUSED BY THE EXCESSIVE AMOUNT OF SILICONE THAT IS DISPENSED DURING THE SILICONIZATION OF THE CATHETER TIP TIPPER. FOR MORE DETAILS ON ROOT CAUSE CHECK CAPA # (B)(4).

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS RECEIVED FROM THE CUSTOMER FACILITY FOR INVESTIGATION. BD RECEIVED ONE OPEN AND UNUSED SAMPLE OF ANGIOCATH 24GX0.75; CATALOG: 381112; BATCH: 6180339. A VISUAL ANALYSIS WAS PERFORMED ON THE SAMPLE, WHICH CONFIRMED THE PRESENCE OF SILICONE DROPS ON THE CATHETER. THUS, THE COMPLAINT PREVIOUSLY PERFORMED BASED ON THE PHOTOS WILL REMAIN UNCHANGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD ANGIOCATH¿ IV CATHETER WAS FOUND BEFORE USE WITH FOREIGN MATTER IN SURFACE OF THE CATHETER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841329 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 6180339 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other