BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT-A-CATH® PLASTIC HUB BENT NEEDLE

    MDR report key: 5091467 · Received September 21, 2015

    Report

    Report Number
    2183502-2015-00676
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    June 26, 2015
    Report Date
    September 21, 2015
    Manufacturer
    SMITHS MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K830730
    Removal / Correction Number
    2183502-08/31/2015-006-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL'S INVESTIGATION CONFIRMED THAT FOR SOME OF THE AFFECTED LOT NUMBER (46262), THE UNIT PACK LID LABEL INCORRECTLY LISTED PART NUMBER 21-2005-24 (PORT-A-CATH® PLASTIC HUB STRAIGHT NEEDLE) RATHER THAN CORRECT PART NUMBER 21-2287-24 (PORT-A- CATH® PLASTIC HUB BENT NEEDLE). THEREFORE, THE CORRECT PRODUCT WAS INCLUDED IN THE UNIT PACK BUT THE UNIT PACK WAS LABELED INCORRECTLY. THIS ISSUE WAS DETERMINED TO HAVE OCCURRED DUE TO AN ERROR DURING LINE CLEARANCE WHERE THE INCORRECT UNIT PACK LABELS WERE USED. MANUFACTURING WILL BE MODIFYING BOTH THE LINE CLEARANCE PROCEDURE AND THE INSPECTION PROCEDURE TO BETTER ADDRESS THE POTENTIAL FOR THIS ISSUE. SPECIFICALLY, THE LINE CLOSURE PROCESS WILL BE UPDATED TO INCLUDE LABEL VERIFICATION; BOTH AT START OF MANUFACTURING AND ONE AT LINE CLOSURE. THE UPDATED PROCESS WILL ALSO REQUIRE THESE TWO LABELS (ONE AT START AND ONE AT CLOSE) TO MATCH. ALSO, THE RE-WORK PROCEDURE WILL BE UPDATED TO INCLUDE AN INSPECTION STEP AND INSTRUCTIONS REGARDING DOCUMENTATION OF PRODUCT RE-WORK WITHIN THE DEVICE HISTORY RECORDS. SMITHS MEDICAL HAS INITIATED A FIELD SAFETY CORRECTIVE ACTION FOR THIS ISSUE TO RECALL LOT NUMBER 46262. THIS ACTION WAS INITIATED WITH CUSTOMERS STARTING SEPTEMBER 2015.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE INCORRECT PRODUCT WAS INCLUDED WITHIN THE PRODUCT SHELF CARTON. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621445 PORT-A-CATH® PLASTIC HUB BENT NEEDLE NEEDLE, SUBCUTANEOUS INJECTION/INFUSION PORT LJT SMITHS MEDICAL NA 46262

    Patients

    Seq Age Sex Outcome Treatment
    1