BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PRO SAFETY CATHETER

    MDR report key: 7636537 · Received June 25, 2018

    Report

    Report Number
    2243072-2018-00390
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    May 31, 2018
    Report Date
    September 20, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURER¿S INVESTIGATION WAS PERFORMED TO REVIEW THE ISSUE WITH THE SUPPLIER. IT WAS IMMEDIATELY NOTED THAT THE ISSUE DOES NOT CORRESPOND TO THE IMAGES PROVIDED. THE PICTURE PROVIDED SHOWS THE NEEDLE IS STILL WITHIN THE CATHETER AND THE SAFETY SYSTEM STILL HAS NOT BEEN ACTIVATED. THE INTRODUCER NEEDLE SHOULD DETACH FROM THE CATHETER AND ITS TIP WOULD BE COVERED BY THE SAFETY SYSTEM. HOWEVER, IT APPEARS THE USER HAS TRIED TO CLOSE THE LOCKER WHEN THE NEEDLE WAS NOT FULLY REMOVED FROM THE CANNULA AND CATHETER HUB. IN REVIEW, 15 UNITS OF A REPRESENTATIVE SAMPLE FOR THIS LOT WERE LEAK TESTED AND SHOWED NO INDICATION OF ANY DEFECTS. FURTHERMORE, BATCH RECORD DATA WAS REVIEWED AND A REVIEW OF SUBSEQUENT LOTS WAS PERFORMED AND THERE WERE NO REPORTS WHICH INDICATED ANY DEFECTIVE PRODUCT. THE LOTS CONFORMED TO MEET PRODUCT SPECIFICATIONS. PLEASE NOTE THAT THE ROOT CAUSE FOR THIS FAILURE WAS NOT RELATED TO THE MANUFACTURING PROCESS AND WAS LIKELY AN OUTCOME OF A DEVICE MALFUNCTION AFTER IMPROPER USE OF THE DEVICE. SHOULD AN ORIGINAL SAMPLE DEVICE WITH THE ISSUE BECOME AVAILABLE FOR THIS COMPLAINT AN ADDITIONAL INVESTIGATION MAY BE PERFORMED FOR DETERMINATION OF THE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN AN ANESTHESIOLOGIST REMOVED A BD PRO SAFETY CATHETER, LEAKAGE OCCURRED. AS STATED " THE SAFETY PLUS TURNED THE LOCKER IN CLOSED POSITION BLOOD DID ANYWAY PASS THROUGH." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION, WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN.  DEVICE MANUFACTURE DATE: UNKNOWN. BATCH 1170616 DOES NOT EXIST FOR MATERIAL (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN AN ANESTHESIOLOGIST REMOVED A BD¿ PRO SAFETY CATHETER, LEAKAGE OCCURRED. AS STATED " THE SAFETY PLUS TURNED THE LOCKER IN CLOSED POSITION BLOOD DID ANYWAY PASS THROUGH." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475865 BD¿ PRO SAFETY CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 1170616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other