BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8586742 · Received May 7, 2019

    Report

    Report Number
    1710034-2019-00505
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 15, 2019
    Report Date
    June 6, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825333
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BD RECEIVED A 20 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNIT FROM AN UNKNOWN LOT. THE DEVICE WAS RECEIVED OUTSIDE OF ITS ORIGINAL PACKAGING SO A LOT NUMBER COULD NOT BE DETERMINED. HOWEVER, IT WAS PROVIDED THAT THE UNIT COULD BELONG TO TWO DIFFERENT LOTS, 8310635 AND 8200662. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR BOTH LOTS AND NO RELATED QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED A CLEAR WHITE PARTICLE ON THE CATHETER TUBING. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS PARTICLE WAS A PLUG SHAVING FROM THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO: 382533 BATCH NO: UNKNOWN (8310635 OR 8200662). IT WAS REPORTED THAT NURSE DISCOVERED A PIECE OF WHITE FRAGMENT AT BEVEL OF NEEDLE. PER CUSTOMER EMAIL: APRIL 15, 2019, PRIOR TO USE NURSE REPORTED ¿ INSPECTION OF IV CATHETER NOTICED A PIECE OF WHITE FRAGMENT AT BEVEL OF NEEDLE.¿ PRODUCT NOT USED AND IS AVAILABLE FOR REVIEW. SECOND IV CATHETER OPENED, APPEARED OK AND USED. BOTH PACKAGES WERE SAVED, UNCERTAIN WHICH LOT NUMBER HAD FRAGMENTED PIECE ATTACHED. THE TWO (2) LOT NUMBERS ARE #8310635 AND LOT #8200662."

    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 #: 8310635, MEDICAL DEVICE EXPIRATION DATE: 2021-10-31, DEVICE MANUFACTURE DATE: 2018-11-06. MEDICAL DEVICE LOT #: 8200662, MEDICAL DEVICE EXPIRATION DATE: 2021-06-30, DEVICE MANUFACTURE DATE: 2018-07-19. DEVICE EVALUATED BY MFR: 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 OCCURRED WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO: 382533 BATCH NO: UNKNOWN (8310635 OR 8200662). IT WAS REPORTED THAT NURSE DISCOVERED A PIECE OF WHITE FRAGMENT AT BEVEL OF NEEDLE. PER CUSTOMER EMAIL: ON (B)(6) 2019, PRIOR TO USE NURSE REPORTED ¿ INSPECTION OF IV CATHETER NOTICED A PIECE OF WHITE FRAGMENT AT BEVEL OF NEEDLE.¿ PRODUCT NOT USED AND IS AVAILABLE FOR REVIEW. SECOND IV CATHETER OPENED, APPEARED OK AND USED. BOTH PACKAGES WERE SAVED, UNCERTAIN WHICH LOT NUMBER HAD FRAGMENTED PIECE ATTACHED. THE TWO (2) LOT NUMBERS ARE #8310635 AND LOT #8200662."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378554 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other