BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAUT CHOLANGIOGRAM CATHETER 10/BOX 4.5 FR TIP

    MDR report key: 3886404 · Received April 10, 2014

    Report

    Report Number
    3003898360-2014-00220
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GBZ
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE NOT RECEIVED BY MFG. PER DHR THE PRODUCT TAUT CHOLANG CATH10/BX 4.5 FR TIP X 30, LOT # 01A1400037 WAS MANUFACTURED ON 01/08/2014 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 01/09/2014. CORRECTIVE ACTIONS: PERSONNEL WAS NOTIFIED OF THE MISSING SUPPORT TUBE; THE DEVICE DOCUMENTATION WAS REVISED TO ESTABLISH THE NECESSARY CONTROLS TO PREVENT RE-OCCURRENCE OF THIS ISSUE. DHR REVIEW CONFIRMED DEFECT REPORTED BY CUSTOMER "WRING SIZE PRODUCT IN PACKAGE". THE OPERATOR CONFUSED THE 18400 OPERATION, THAT REQUIRES CRIMPING, WITH THE 18305, THAT DOES NOT REQUIRE THIS OPERATION. THIS IS WHY THE CUSTOMER REPORTED THE 18305'S INSIDE OF THE PACKAGING. PERSONNEL WERE MADE AWARE OF THE MISSING SUPPORT TUBE AND CONTROLS WERE ESTABLISHED TO PREVENT RE-OCCURRENCE. IS NOTED THAT THIS DEFECT IS ISOLATED ONLY TO LOT 01A1400037 AND THAT NO OTHER LOTS WERE AFFECTED, HOWEVER, WE WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED ISSUE: CUSTOMER CALLED TO REPORT THAT WHEN STAFF CHECKED DEVICE, THE METAL SUPPORT TUBES ARE MISSING. NO REPORTED PT INJURY. PT'S CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216638 TAUT CHOLANGIOGRAM CATHETER 10/BOX 4.5 FR TIP CHOLANGIOGRAM CATHETER GBZ TELEFLEX 01A1400037

    Patients

    Seq Age Sex Outcome Treatment
    1