BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ARTERIAL CANNULA WITH FLOSWITCH

    MDR report key: 16713672 · Received April 11, 2023

    Report

    Report Number
    8041187-2023-00151
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    March 7, 2023
    Report Date
    May 18, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382906822451
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 24-APR-2023. H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 1 SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF CATHETER BROKE / SEPARATED AFTER PLACEMENT WAS CONFIRMED UPON INSPECTION OF THE SAMPLE. ANALYSIS OF THE SAMPLE SHOWED THAT THE CATHETER WAS SMOOTHLY CUT OFF BY THE BASE OF THE CATHETER TUBING. THE MANUFACTURING PROCESS WAS REVIEWED AND THERE ARE NO PROCESSES THAT COULD PRODUCE THE DAMAGES OBSERVED ON THE RETURNED SAMPLE. A SIMULATION WAS PERFORMED BY USING SCISSORS TO CUT PART OF ADDITIONAL CATHETER MATERIAL. THE RESULTING CUT WAS VERY SIMILAR TO THE CUT OBSERVED ON THE RETURNED SAMPLE. SINCE THE RETURNED SAMPLE WAS RETURNED USED, WE CANNOT CONFIRM THIS POTENTIAL ROOT CAUSE, BUT IF SHARP OBJECT SUCH AS SCISSORS WERE NEAR OR AROUND THE SAMPLE, THERE IS THE POSSIBILITY THEY COULD HAVE CAUSE THE OBSERVED CUT. ONCE AGAIN SINCE THE PRODUCT WAS RETURNED USE THAT ROOT CAUSE CANNOT BE CONFIRMED. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ARTERIAL CANNULA WITH FLOSWITCH BROKE OFF INSIDE THE PATIENT'S BODY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: WE ARE HEREBY INFORMING YOU OF AN ACCIDENT REPORT FOR THE ARTERIAL CANNULA CODE 682245 LOT 2231224. THEY REPORT THAT AT THE END OF THE PROCEDURE, THE ARTERIAL CATHETER WAS REMOVED AS USUAL, AND AT THE TIME OF REMOVAL, WHICH WAS AS SMOOTH AS EVER, IT WAS FOUND THAT OUT OF 45MM OF CANNULA, 40MM REMAINED INSIDE THE ARTERY. THE ANAESTHETIST PROCEEDED TO ULTRASOUND THE ARTERY ITSELF, CONFIRMING THE PRESENCE OF THE CATHETER SEGMENT. A DISCUSSION IS HELD WITH THE PRESENT VASCULAR SURGEON AND IT IS DECIDED TO HAVE IT SURGICALLY REMOVED IN THE EMERGENCY SECTOR (ROOM ALREADY OCCUPIED BY ANOTHER SCHEDULED PATIENT). THEY ADVISE THAT THE SAMPLE IS AVAILABLE, AS SOON AS IT IS IN OUR WAREHOUSE, WE WILL NOTIFY YOU. DEVICE CODE 682245, LOT NUMBER 2231224, EXPIRY DATE 31/08/2027. IMPLANT DATE (B)(6) 2023. THE DEVICE WAS USED. REASON FOR USE: LEFT ARM RADIAL ARTERY CANNULATION FOR INTRAOPERATIVE INVASIVE PA MEASUREMENT IN PATIENT UNDERGOING TEA SURGERY RIGHT CAROTID ARTERY. DEVICE USED THROUGHOUT SURGERY: 8.00-10.20.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ARTERIAL CANNULA WITH FLOSWITCH BROKE OFF INSIDE THE PATIENT'S BODY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: WE ARE HEREBY INFORMING YOU OF AN ACCIDENT REPORT FOR THE ARTERIAL CANNULA CODE 682245 LOT 2231224. THEY REPORT THAT AT THE END OF THE PROCEDURE, THE ARTERIAL CATHETER WAS REMOVED AS USUAL, AND AT THE TIME OF REMOVAL, WHICH WAS AS SMOOTH AS EVER, IT WAS FOUND THAT OUT OF 45MM OF CANNULA, 40MM REMAINED INSIDE THE ARTERY. THE ANAESTHETIST PROCEEDED TO ULTRASOUND THE ARTERY ITSELF, CONFIRMING THE PRESENCE OF THE CATHETER SEGMENT. A DISCUSSION IS HELD WITH THE PRESENT VASCULAR SURGEON AND IT IS DECIDED TO HAVE IT SURGICALLY REMOVED IN THE EMERGENCY SECTOR (ROOM ALREADY OCCUPIED BY ANOTHER SCHEDULED PATIENT) THEY ADVISE THAT THE SAMPLE IS AVAILABLE, AS SOON AS IT IS IN OUR WAREHOUSE, WE WILL NOTIFY YOU. DEVICE CODE 682245, LOT NUMBER 2231224, EXPIRY DATE 31/08/2027. IMPLANT DATE (B)(6) 2023. THE DEVICE WAS USED. REASON FOR USE: LEFT ARM RADIAL ARTERY CANNULATION FOR INTRAOPERATIVE INVASIVE PA MEASUREMENT IN PATIENT UNDERGOING TEA SURGERY RIGHT CAROTID ARTERY. DEVICE USED THROUGHOUT SURGERY: 8.00-10.20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720936 BD ARTERIAL CANNULA WITH FLOSWITCH INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2231224 00382906822451

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Required Intervention