BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER 22G X 1.16 IN

    MDR report key: 6831983 · Received August 30, 2017

    Report

    Report Number
    9610048-2017-00018
    Event Type
    Malfunction
    Date Received
    August 30, 2017
    Date of Event
    August 7, 2017
    Report Date
    January 9, 2018
    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

    CORRECTION: MEDICAL DEVICE CATALOG # - 381123.

    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).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: INVESTIGATION SUMMARY: SAMPLES/ PHOTOS: WERE RECEIVED PHOTOS OF THE CLAIMED PRODUCT AND AFTER ANALYSIS OF THE BD USA AND 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: 6084423 (TIPPER LOT / ASSEMBLED SET: 6060038) 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. BD WAS ABLE TO CONFIRM/ REPRODUCE THE INCIDENT IN QUESTION. INVESTIGATION CONCLUSION: THE PHOTOS RECEIVED AND THE ANALYSIS OF THE SAMPLES CARRIED OUT BY THE USA WITH THE SAMPLES RETURNED FROM THE CLIENT, 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. ROOT CAUSE DESCRIPTION: 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. FOR MORE DETAILS OF THE ROOT CAUSE TO CHECK CAPA # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE CATHETER OF A BD ANGIOCATH¿ IV CATHETER 22G X 1.16 IN BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613162 BD ANGIOCATH¿ IV CATHETER 22G X 1.16 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 6084423

    Patients

    Seq Age Sex Outcome Treatment
    1 Other