BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BLOOD CONTROL

    MDR report key: 13660788 · Received March 3, 2022

    Report

    Report Number
    1710034-2022-00106
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    February 21, 2022
    Report Date
    May 2, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 14-APR-2022. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED 24G X 0.75IN. INSYTE AUTOGUARD BC PRO UNIT FROM LOT NUMBER 1172748. ADDITIONALLY, SIX PHOTOS WERE RECEIVED FOR INVESTIGATION. THE UNIT WAS RETURNED WITH NEEDLE RETRACTED. A GROSS VISUAL INSPECTION DID NOT IDENTIFY ANY DAMAGE TO THE COMPONENTS. FUNCTIONAL TESTING WAS PERFORMED BY UNRETRACTING THE NEEDLE AND ATTEMPTING RETRACTION. UPON RETRACTION THE NEEDLE HUB WAS STOPPED MIDWAY THROUGH RETRACTION. THE UNIT WAS MICROSCOPICALLY INSPECTED, AND THE BUTTON WAS FOUND TO BE DEFORMED. THE DEFORMITY WAS CAUSING THE BUTTON TO BE MISALIGNED AND CAUSING INTERFERENCE WITH THE NEEDLE HUB. THE BUTTON WAS CAREFULLY REMOVED FROM THE GRIP FOR FURTHER INSPECTION. THE DEFORMATION SEEN ON THE BUTTON APPEARED AS THOUGH THE MATERIAL AT THE CORNER OF THE BUTTON HAD BEEN MELTED. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO ASSEMBLY AND MOLDING AS A POTENTIAL ORIGIN OF THIS DEFECT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BLOOD CONTROL THE NEEDLE WOULD NOT RETRACT PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER'S REPORT IS AS FOLLOWS: AFTER VENIPUNCTURE, THE HCP PRESSED THE BUTTON TO RETRACT THE NEEDLE; HOWEVER, THE SAFETY MECHANISM DIDN'T WORK.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BLOOD CONTROL THE NEEDLE WOULD NOT RETRACT PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER'S REPORT IS AS FOLLOWS: AFTER VENIPUNCTURE, THE HCP PRESSED THE BUTTON TO RETRACT THE NEEDLE; HOWEVER, THE SAFETY MECHANISM DIDN'T WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364522 BD INSYTE¿ AUTOGUARD¿ BLOOD CONTROL INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1172748

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown