BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7196722 · Received January 16, 2018

    Report

    Report Number
    9610048-2017-00109
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    December 21, 2017
    Report Date
    February 20, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AN ADDITIONAL LOT WAS ADDED TO THE COMPLAINT. MEDICAL DEVICE LOT #: 6253499, MEDICAL DEVICE EXPIRATION DATE: 08/31/2021, DEVICE MANUFACTURE DATE: 09/20/2016. INVESTIGATION SUMMARY: CONFIRMED: BD WAS ABLE TO CONFIRM/ REPRODUCE THE INCIDENTS IN QUESTION. SILICONE VISIBLE: AFTER ANALYZING THE PHOTOS RETURNED FROM THE CLIENT, IT WAS POSSIBLE TO CONFIRM THE PRESENCE OF SILICONE DROPS IN THE CATHETER AND FOREIGN MATTER. 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. FOREIGN MATTER: IN ADDITION, THE ANALYSIS OF THE PHOTOS CONTAINING THE CLAIMED SAMPLES ALSO EVIDENCED FOREIGN MATTER INSIDE THE PACKAGE. SAMPLES/ PHOTOS: ACCORDING TO THE VISUAL ANALYSIS OF THE RECEIVED PHOTOS, IT WAS POSSIBLE TO VERIFY THE PRESENCE OF SILICONE DROPS IN THE CATHETER AND PARTICLES OF FOREIGN MATTER INSIDE THE PACKAGE. 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 CHANGING THE INVESTIGATION CARRIED OUT. DHR/ QN/ NCMR REVIEW: THE FINAL ASSEMBLY LOT: 6361823 E 6232119 USED IN THE CLAIMED FINAL PRODUCT LOT: 7010867 E 6253499 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. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO CONFIRM/ REPRODUCE THE INCIDENTS IN QUESTION. SILICONE VISIBLE: AFTER ANALYZING THE PHOTOS RETURNED FROM THE CLIENT, IT WAS POSSIBLE TO CONFIRM THE PRESENCE OF SILICONE DROPS IN THE CATHETER AND FOREIGN MATTER. 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. FOREIGN MATTER: IN ADDITION, THE ANALYSIS OF THE PHOTOS CONTAINING THE CLAIMED SAMPLES ALSO EVIDENCED FOREIGN MATTER INSIDE THE PACKAGE. ROOT CAUSE DESCRIPTION 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. ROOT CAUSE DETAILS CONTAINED IN CAPA # (B)(4). FOR COMPLAINT OF FOREIGN MATTER, BASED ON THE RESULTS OF THE INVESTIGATION SO FAR IT CAN BE VERIFIED THAT THE FOREIGN MATTER MAY HAVE BEEN CAUSED DURING THE PACKAGING PROCESS. HOWEVER, THE EXACT ROOT CAUSE FOR THIS COMPLAINT WAS NOT FOUND.

    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 THERE WAS A ¿WATER DROP¿ FOUND ON THE CATHETER TIP OF A BD ANGIOCATH¿ IV CATHETER PRIOR TO USE. THE HEALTH CARE PROFESSIONAL WIPED THE ¿WATER DROP¿ OFF. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41016 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7010867 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other