BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24 G X 0.75 IN. BD ANGIOCATH¿

    MDR report key: 6815294 · Received August 23, 2017

    Report

    Report Number
    9610048-2017-00019
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    July 28, 2017
    Report Date
    October 25, 2017
    Manufacturer
    BECTON DICKINSON INDUSTRIAS 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

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    SAMPLES/ PHOTOS: ACCORDING TO THE VISUAL ANALYSIS OF THESE PHOTOS, IT WAS POSSIBLE TO CONFIRM THE PRESENCE OF SILICONE DROPLETS ON THE CATHETER. DHR REVIEW: AFTER ANALYSIS OF THE CLAIMED LOT: 6180339 (TIPPER LOT/ASSEMBLED SET: 6179393 AND 6152234SH) NO SILICONE EXCESSIVE WAS VERIFIED IN THE TESTS CARRIED OUT DURING THE PRODUCTION OF THE LOTS IN QUESTION. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NON-CONFORMITY REPORT RECORDS OF THIS DEFECT FOR THE LOTS INVOLVED IN THIS COMPLAINT, ACCORDING TO THE DHR OF THE LOT ABOVE. CONFIRMED: BD WAS ABLE TO CONFIRM/ REPRODUCE THE INCIDENT IN QUESTION. INVESTIGATION COMMENTS: ACCORDING TO THE PHOTOS CONTAINING THE SAMPLES CLAIMED, IT WAS POSSIBLE TO CONFIRM THE PRESENCE OF SILICONE IN THE CATHETER. IT SHOULD BE NOTED THAT THIS SILICONE DOES NO HARM TO THE USER AND IS USED TO AID IN THE SLIPPAGE OF THE CATHETER DURING VENIPUNCTURE. BASED ON INVESTIGATIONS PERFORMED FOR ANGIOCATH NEEDLE CLOGGED COMPLAINTS, IT HAS BEEN FOUND THAT THE ROOT CAUSE OF BOTH CLOGGING AND EXCESS SILICONE OVER THE CATHETER IS CAUSED BY THE EXCESSIVE AMOUNT OF SILICONE THAT IS DISPENSED DURING SILICONIZATION OF THE CATHETER IN THE TIPPER MACHINES. THE (B)(4) THAT WAS OPENED TO HANDLE THE CLOGGED NEEDLE COMPLAINTS OF THE ANGIOCATH IT WILL ALSO COVER THE COMPLAINTS OF EXCESS SILICONE OVER THE ANGIOCATH PRODUCT CATHETER, SINCE THE VALIDATIONS OF THE TIPPERS MACHINES WERE INCLUDED AMONG THE CORRECTIVE ACTIONS, WITH THE OBJECTIVE OF REDUCING THE AMOUNTS OF EXCESS SILICONE DISPENSED ON THE CATHETERS DURING THE CATHETER TIPPING PROCESS. THUS, IT IS BELIEVED THAT THE AMOUNT OF SILICONE THAT IS VISUALLY OBSERVED AS DROPLETS ON THE CATHETER WILL BE CONSIDERABLY REDUCED WHICH MAY RESULT IN IMPROVEMENT IN THE VISUAL ASPECT OF THE PRODUCT TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON A 24 G X 0.75 IN. BD ANGIOCATH¿ PRIOR TO USE. NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593191 24 G X 0.75 IN. BD ANGIOCATH¿ INTERVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 6180339

    Patients

    Seq Age Sex Outcome Treatment
    1 Other