BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL

    MDR report key: 7660689 · Received July 3, 2018

    Report

    Report Number
    1710034-2018-00380
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 14, 2018
    Report Date
    August 17, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE RETURNED IN SUPPORT OF THIS COMPLAINT. THE DEFECT FOREIGN MATTER; AS STATED AS THE REPORTED CODE 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. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE TIP OF A BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER WITH BLOOD CONTROL BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7240671; MEDICAL DEVICE EXPIRATION DATE: 08/31/2020; DEVICE MANUFACTURE DATE: 08/28/2017. MEDICAL DEVICE LOT #: 8002876; MEDICAL DEVICE EXPIRATION DATE: 12/31/2020; DEVICE MANUFACTURE DATE: 01/02/2018. 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 THAT FOREIGN MATTER WAS FOUND ON THE TIP OF A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499972 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10. 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other