BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOCATH-T 20G 1-1/4IN

    MDR report key: 3251702 · Received July 10, 2013

    Report

    Report Number
    3005515211-2013-00005
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 13, 2013
    Manufacturer
    AMSINO MEDICAL CO., LTD, CONTRACT MFR FOR HOSPIRA, INC.
    Product Code
    FOZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. A REP DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT AS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FOZ AND IS PRE-AMENDMENT 510K. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    ADVERSE INCIDENT REPORT WAS RECEIVED FROM (B)(6) THAT STATED THE FOLLOWING: "AS PART OF PT PREPARATION FOR INDUCTION OF ANAESTHESIA AND SURGERY, I WAS INSERTING AN ARTERIAL LINE IN THE PT'S LEFT WRIST. LOCAL ANAESTHETIC WAS INFILTRATED AND THEN I CANNULATED THE ARTERY WITH A SHORT ARTERIAL CANNULA WHICH IS FREQUENTLY USED IN THE DEPARTEMENT AND I HAD USED IT IN THE PAST 3 MONTHS IN THE CARDIAC THEATRES. I CANNULATED THE ARTERY WITHOUT ANY PROBLEMS. AS I WAS WAITING FOR THE CANNULA TO BE CONNECTED TO THE APPROPRIATE TUBING, I SAW BLOOD COMING OUT FROM WHAT SEEMED AROUND THE CANNULA. AS MY 2ML SYRINGE WAS STILL ATTACHED TO THE HUB I NOTICED THAT THE HUB HAD ACTUALLY BROKEN OFF THE CANNULA LEAVING BEHIND THE CANNULA IN THE PT'S LEFT RADIAL ARTERY. AT THE POINT I TRIED AND MANAGED TO PULL THE CANNULA OUT OF THE PT'S ARTERY AS THERE WAS A SMALL PIECE OF PLASTIC STILL ATTACHED TO IT." UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED THAT INDICATED THE IV CATHETER BROKE OFF. THE PT WAS ADMITTED FOR AN UNSPECIFIED CARDIAC SURGERY AND WAS BEING PREPARED FOR INDUCTION OF ANESTHETIST INSERTED THE CATHETER INTO THE PT'S LEFT RADIAL ARTERY TO MONITOR ARTERIAL BLOOD PRESSURE AND ARTERIAL BLOOD GAS SAMPLING. THE CUSTOMER CONTACT STATED THAT THE ARTERY AS CANNULATE WITHOUT DIFFICULTY. IT WAS REPORTED THAT A 2ML SYRINGE WAS CONNECTED TO THE CATHETER HUB. THE CUSTOMER CONTACT STATED WHILE WAITING FOR THE TUBING SET TO BE CONNECTED TO CATHETER HUB, THAT THE ANESTHETIST NOTED AN UNSPECIFIED VOLUME OF BLOOD LEAKED FROM AN UNSPECIFIED LOCATION AROUND THE CATHETER CANNULA. AT THAT TIME, THE ANESTHETIST NOTED THAT THE CATHETER HUB HAD BROKEN OFF AND THE DISTAL PORTION OF THE CATHETER REMAINED IN THE PT'S LEFT RADIAL ARTERY. THE DISTAL PORTION OF THE CATHETER END WAS REMOVED FROM THE PT AND A PRESSURE DRESSING WAS APPLIED. NO SPECIFIC DETAILS WERE PROVIDED. THE CATHETER AND THE PT'S ARTERIAL LINE ACCESS SITE WERE REPLACED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317935 ABBOCATH-T 20G 1-1/4IN 80FOZ FOZ AMSINO MEDICAL CO., LTD, CONTRACT MFR FOR HOSPIRA, INC. NA 23207KY

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention