BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC BLU 22GA X 1.0IN

    MDR report key: 11083710 · Received December 28, 2020

    Report

    Report Number
    1710034-2020-00831
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    November 18, 2020
    Report Date
    February 16, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. DHR COULD NOT BE PERFORMED DUE TO THE UNKNOWN LOT#. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOG BC BLU 22GA X 1.0IN WAS DAMAGED AND LEAKED AIR AND BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382523 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT CATHETER CONTINUED TO LEAK AIR AND DRIP BLOOD FROM THE CONNECTION SITE. EVENT DESCRIPTION: ON 23-NOV-2020, PRODUCT SURVEILLANCE RECEIVED AN EMAIL REGARDING OL PI STD BORE EXT SET. THE CUSTOMER REPORTED THAT THEY INITIATED 22-GAUGE SALINE LOCK; HOWEVER, MULTIPLE BUBBLES WERE NOTED DURING FLASH-BACK OF BLOOD. SALINE LOCK WAS FLUSHED WELL BUT CONTINUED TO LEAK AIR AND DRIP BLOOD FROM CONNECTION SITE. THEY ATTEMPTED TO ADJUST THE CONNECTION WITHOUT SUCCESS. CRN CALLED IN AND ATTEMPTED SAME WITHOUT SUCCESS. NEW CONNECTION WAS PUT IN PLACE BUT CONTINUED TO LEAK BLOOD. STAFF DETERMINED IT WAS A MALFUNCTION WITH THE NEEDLE HUB. PACKAGING WAS DISPOSED OF BEFORE LOT NUMBER WAS OBTAINED. THE DATE OF EVENT WAS ON (B)(6) 2020. THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT INJURY AND NO MEDICAL INTERVENTION REPORTED FOR THIS CASE. ON 30-NOV-2020, PRODUCT SURVEILLANCE RECEIVED AN EMAIL FROM THE CUSTOMER FOR THE DUE DILIGENCE. IT WAS REPORTED THAT THE NEEDLE HUB WAS A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY, NON-WINGED 382523 AND THAT LOT NUMBER WAS NOT AVAILABLE BECAUSE THE PACKAGING WAS DISPOSED OF BEFORE THE EVENT WAS REPORTED. THERE WAS ONLY ONE 7N8301 ALLEGED FOR THIS EVENT. THE CUSTOMER STATED THAT THE EVENT OCCURRED IN A CANADIAN HOSPITAL AND WILL BE REPORTED TO CANADIAN MEDICAL DEVICES SENTINEL NETWORK.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE AUTOG BC BLU 22GA X 1.0IN WAS DAMAGED AND LEAKED AIR AND BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382523 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT CATHETER CONTINUED TO LEAK AIR AND DRIP BLOOD FROM THE CONNECTION SITE. EVENT DESCRIPTION: ON (B)(6) 2020, PRODUCT SURVEILLANCE RECEIVED AN EMAIL REGARDING OL PI STD BORE EXT SET. THE CUSTOMER REPORTED THAT THEY INITIATED 22-GAUGE SALINE LOCK; HOWEVER, MULTIPLE BUBBLES WERE NOTED DURING FLASH-BACK OF BLOOD. SALINE LOCK WAS FLUSHED WELL BUT CONTINUED TO LEAK AIR AND DRIP BLOOD FROM CONNECTION SITE. THEY ATTEMPTED TO ADJUST THE CONNECTION WITHOUT SUCCESS. CRN CALLED IN AND ATTEMPTED SAME WITHOUT SUCCESS. NEW CONNECTION WAS PUT IN PLACE BUT CONTINUED TO LEAK BLOOD. STAFF DETERMINED IT WAS A MALFUNCTION WITH THE NEEDLE HUB. PACKAGING WAS DISPOSED OF BEFORE LOT NUMBER WAS OBTAINED. THE DATE OF EVENT WAS ON (B)(6) 2020. THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT INJURY AND NO MEDICAL INTERVENTION REPORTED FOR THIS CASE. ON (B)(6) 2020, PRODUCT SURVEILLANCE RECEIVED AN EMAIL FROM THE CUSTOMER FOR THE DUE DILIGENCE. IT WAS REPORTED THAT THE NEEDLE HUB WAS A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY, NON-WINGED (B)(4) AND THAT LOT NUMBER WAS NOT AVAILABLE BECAUSE THE PACKAGING WAS DISPOSED OF BEFORE THE EVENT WAS REPORTED. THERE WAS ONLY ONE (B)(4) ALLEGED FOR THIS EVENT. THE CUSTOMER STATED THAT THE EVENT OCCURRED IN A (B)(6) HOSPITAL AND WILL BE REPORTED TO CANADIAN MEDICAL DEVICES SENTINEL NETWORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545829 INSYTE AUTOG BC BLU 22GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 UNKNOWN 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1