BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHORT PORT BTT W/CDC SEAL, 5 PACK

    MDR report key: 1940776 · Received December 22, 2010

    Report

    Report Number
    2242352-2010-03756
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 1, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K030512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE SHORT PORT SILICON COATING AND LATEX BALLOON WERE TORN. THE GRAY SEAL WAS NOT RETURNED. THERE WAS NO EVIDENCE OF BLOOD PRESENTS ON THE DEVICE. BASED UPON THE VISUAL OBSERVATIONS, THE COMPLAINT FOR "SHORT PORT RUPTURED" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SHORT PORT BTT (BLUNT TIP TROCAR) RUPTURED DURING USE, OUTSIDE THE PT. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHORT PORT BTT W/CDC SEAL, 5 PACK SHORT PORT BTT GCJ MAQUET CARDIOVASCULAR, LLC 13495 25013177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other