BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACENTESIS TRAY 14G X 2 W/CATH

    MDR report key: 2851657 · Received November 29, 2012

    Report

    Report Number
    1625685-2012-00052
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 8, 2012
    Manufacturer
    CAREFUSION
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE (1) SAMPLE WAS PROVIDED FOR EXAMINATION. EXAMINATION OF THE CATHETER ASSEMBLY NOTED THE CATHETER HUB PARTIALLY CRIMPED TO THE CATHETER BODY. THE CRIMPING MARKS WERE PLACED APPROXIMATELY 1MM AWAY FROM THE EDGE OF THE CATHETER GUARD. A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES IDENTIFIED A SPECIFIC MANUFACTURING STEP FOR TESTING OF THE CATHETER ASSEMBLY. IT WAS NOTED THAT ALL FINISHED UNITS ARE INSPECTED PRIOR TO PLACEMENT IN THE SHIPPING CASE. ANY DEFECTIVE UNITS WILL BE CULLED FROM THE MANUFACTURING PROCESS AND EITHER REWORKED OR DISCARDED PRIOR TO PACKAGING. A REVIEW OF THE MANUFACTURING DEVICE HISTORY RECORD (DHR), RAW MATERIAL HISTORY FILES, AND THE STERILIZATION BATCH RECORDS FOR THE LISTED MANUFACTURING LOT SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE FOR THE REPORTED CONDITION WAS IDENTIFIED AS INSUFFICIENT CRIMPING. CRIMPING IS THE OPERATION THAT MECHANICALLY ATTACHES THE NEEDLE HUB TO THE EXTERIOR WALL OF THE CATHETER GUARD DISTAL END. BASED ON THE IDENTIFIED ROOT CAUSE, ALL APPLICABLE MANUFACTURING PERSONNEL WILL RECEIVE REMEDIAL TRAINING ON THE PROPER PROCEDURES AND TECHNIQUES FOR THE MANUFACTURE OF THE THORACENTESIS CATHETER. ALL APPLICABLE QUALITY PERSONNEL WILL BE NOTIFIED OF THIS REPORT IN AN EFFORT TO HEIGHTEN AWARENESS REGARDING THIS DEFECT.

    Description of Event or Problem · 1

    NEEDLE CAME OFF OF COVER DURING PROCEDURE. ON (B)(6) 2012, THE CUSTOMER ((B)(6)) PROVIDED THE FOLLOWING CLARIFIED INFORMATION: WHEN THE PHYSICIAN WENT TO REMOVE THE COVER FROM THE THORACENTESIS NEEDLE, THE WHOLE NEEDLE CAME OFF. THE CUSTOMER ALSO INDICATED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. REQUIRED. ON (B)(6) 2012, THE CUSTOMER PROVIDED A PHOTO AND REPORT THAT INDICATES THE CUSTOMER DOES NOT BELIEVE THE DEFECT COULD CAUSE HARM TO AN EMPLOYEE OR PATIENT. BASED ON THE PHOTOGRAPH PROVIDED BY THE CUSTOMER, THE NEEDLE PART OF THE INTRODUCER BECAME DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORACENTESIS TRAY 14G X 2 W/CATH NEEDLE, CATHETER GCB CAREFUSION 4341B 0000463156

    Patients

    Seq Age Sex Outcome Treatment
    1