BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ARTERIAL CANNULA 20G/1.10MM X 45MM

    MDR report key: 10430434 · Received August 20, 2020

    Report

    Report Number
    8041187-2020-00508
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    March 13, 2020
    Report Date
    August 25, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ARTERIAL CANNULA 20G/1.10MM X 45MM WAS DAMAGED, BUT STILL OPERABLE. IT WAS ALSO REPORTED THAT THE NEEDLE BROKE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I RECEIVED A CALL AT APPROXIMATELY 10AM THIS MORNING FROM COLIN SMITH IN SUPPLIES AT THE ROYAL VICTORIA INFIRMARY WHICH IS A HOSPITAL IN THE NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST. HE WAS REPORTING AN INCIDENT THAT HAD HAPPENED IN THEATRES WITH THE FOLLOWING PRODUCT: 682245 ¿ ARTERIAL CANNULA STRAIGHT WITH WINGS ¿ ARTERIAL FLOSWITCH RED 20G X 45MM ON/OFF TAP PTFE HE INFORMED ME THERE HAD BEEN HARM TO THE PATIENT HOWEVER THE PRODUCT IS NOT AVAILABLE FOR EXAMINATION AND HE DOES NOT KNOW THE BATCH NUMBER. HE IS BASED AT THE ROYAL VICTORIA INFIRMARY. NEWCASTLE UPON TYNE NE1 4LP".

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ARTERIAL CANNULA 20 G/ 1.10 MM X 45 MM WAS DAMAGED, BUT STILL OPERABLE. IT WAS ALSO REPORTED THAT THE NEEDLE BROKE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I RECEIVED A CALL AT APPROXIMATELY 10 AM THIS MORNING FROM (B)(6) IN SUPPLIES AT THE (B)(6) WHICH IS A HOSPITAL IN THE (B)(6) HOSPITALS NHS FOUNDATION TRUST. HE WAS REPORTING AN INCIDENT THAT HAD HAPPENED IN THEATRES WITH THE FOLLOWING PRODUCT: 682245, ARTERIAL CANNULA STRAIGHT WITH WINGS, ARTERIAL FLOSWITCH RED 20 G X 45 MM ON/OFF TAP PTFE. HE INFORMED ME THERE HAD BEEN HARM TO THE PATIENT HOWEVER THE PRODUCT IS NOT AVAILABLE FOR EXAMINATION AND HE DOES NOT KNOW THE BATCH NUMBER. HE IS BASED AT (B)(6). (B)(6) NE1 4LP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899452 BD ARTERIAL CANNULA 20G/1.10MM X 45MM SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other