BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ IV CATHETER

    MDR report key: 5430420 · Received February 11, 2016

    Report

    Report Number
    1710034-2016-00009
    Event Type
    Injury
    Date Received
    February 11, 2016
    Date of Event
    January 25, 2016
    Report Date
    January 29, 2016
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DEVICE USED IN THIS INCIDENT IS UNKNOWN. THE CUSTOMER PROVIDED THE FOLLOWING POSSIBLE LOT NUMBERS: LOT 5293615, CATALOG 381423, DEVICE EXP. DATE: 09/30/2018, DEVICE MANUFACTURE DATE: 10/20/2015, LOT 5225989, CATALOG 381433, DEVICE EXP. DATE: 07/31/2018, DEVICE MANUFACTURE DATE: 08/13/2015, LOT 5278882, CATALOG 381433, DEVICE EXP. DATE: 09/30/2018, DEVICE MANUFACTURE DATE: 10/05/2015, LOT 4261619, CATALOG 381423, DEVICE EXP. DATE: 09/30/2017, DEVICE MANUFACTURE DATE: 09/18/2014, LOT 5198609, CATALOG 381423, DEVICE EXP. DATE: 06/30/2018, DEVICE MANUFACTURE DATE: 07/17/2015, LOT 5071694, CATALOG 381423, DEVICE EXP. DATE: 03/31/2018, DEVICE MANUFACTURE DATE: 09/12/2015. DEVICE EVALUATION: RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE POTENTIAL REPORTED LOT NUMBERS. A CONTROLLED SAMPLE FOR CATHETER/ADAPTER PULL TEST IS REQUIRED FOR RELEASE TO PACKAGING. ALL REPORTED LOT NUMBERS MET SPECIFICATIONS. NO RELATED REJECTED ACTIVITY WAS FOUND FOR THE LOT NUMBERS ASSOCIATED WITH THIS INCIDENT. CONCLUSION - THE CUSTOMER'S REPORTED DEFECT COULD NOT BE IDENTIFIED OR CONFIRMED AND CAUSE COULD NOT BE DETERMINED, AS THE UNITS DESCRIBED IN THE PRODUCT INCIDENT REPORT WERE NOT RETURNED FOR EVALUATION AND TESTING. THEREFORE, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECTS STATED IN THE PIR. THIS INCIDENT IS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A PROCEDURE ON (B)(6) 2016 AND THEN RETURNED TO THE EMERGENCY DEPARTMENT (B)(6) 2016 AS HER HAND WAS SWOLLEN, RED, AND PAINFUL. AN X-RAY WAS PERFORMED AND 2CM OF IV CATHETER WAS FOUND IN THE DORSUM OF HER HAND. THE CATHETER WAS REMOVED BY THE EMERGENCY ROOM STAFF. THE NURSING STAFF HAS TRIED TO DETERMINE HOW THIS INCIDENT OCCURRED, AND AFTER ATTEMPTING TO PULL APART SEVERAL DIFFERENT IV CATHETERS FROM THE HUBS, THEY CAME TO THE CONCLUSION THAT THE SUSPECT IV WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87706 UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ IV CATHETER SHIELDED IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention