BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7207376 · Received January 19, 2018

    Report

    Report Number
    9610048-2017-00116
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    December 27, 2017
    Report Date
    January 23, 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 · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7010867, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2017-01-23, MEDICAL DEVICE LOT #: 6253499, MEDICAL DEVICE EXPIRATION DATE: 08/31/2021, DEVICE MANUFACTURE DATE: 09/09/2016. 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

    OUR QUALITY ENGINEER WAS ABLE TO VERIFY 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. THE ROOT CAUSE WAS DETERMINED TO BE EXCESSIVE AMOUNT OF SILICONE THAT IS DISPENSED DURING THE SILICONIZATION OF THE CATHETER TIP TIPPER. A CORRECTIVE ACTION PROJECT HAS BEEN INITIATED TO INVESTIGATE THE ISSUE. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION AND WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. THE FINAL ASSEMBLY LOT: 6361823 AND 6232119 USED IN THE CLAIMED FINAL PRODUCT LOT: 7010867 AND 6253499 OF ANGIOCATH 24GA X 75IN WAS TESTED FOR PRESENCE OF "FOREIGN/UNFAMILIAR MATTER" AND NO RECORDS OF THIS DEFECT WERE FOUND. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO CONFIRM/REPRODUCE THE INCIDENT IN QUESTION. 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. IT SHOULD BE NOTED THAT THIS TYPE OF COMPLAINT DOES NOT REQUIRE THE PRESENCE OF PHYSICAL SAMPLES, AS LONG AS THE PHOTOS HAVE GOOD RESOLUTION AND CLEARLY SHOW THE DEFECT, AS WAS THE CASE OF THIS COMPLAINT WOULD BE SUFFICIENT TO CONFIRM THE DEFECT. 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 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, A BD ANGIOCATH¿ IV CATHETER WAS FOUND WITH FOREIGN MATTER ON CATHETER. THERE IS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48388 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. SEE H.10 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other