BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTAVAC CBC

    MDR report key: 97669 · Received August 2, 1994

    Report

    Report Number
    97669
    Event Type
    Injury
    Date Received
    August 2, 1994
    Date of Event
    June 8, 1994
    Report Date
    June 20, 1994
    Manufacturer
    STRYKER CORP-MEDICAL
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR LEFT TOTAL KNEE ARTHROPLASTY ON 6/6/94. DRAIN ORDERED DC'D BY PHYSICIAN ON 6/8/94. FIRST TUBE REMOVED WITHOUT DIFFICULTY. NURSE MET RESISTANCE WHILE ATTEMPTING TO REMOVE SECOND LINE. A LOUD POP WAS HEARD, AND THE TUBE WAS OBSERVED TO BE SIX INCHES SHORTER THAN FIRST TUBE. X-RAY IDENTIFIED TUBING PRESENT WITHIN THE JOINT SPACE. PHYSICIAN STATED DRAIN TO BE REMOVED WITH ARTHROSCOPIC PROCEDURE AFTER KNEE HEALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTAVAC CBC REINFUSION DRAIN CAC STRYKER CORP-MEDICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention QUININE @ H.S. 1 OR 2| TRAZODONE 150 @ H.S.| GLYNASE PRESSTABS 3MG 1-1/2 TAB Q.A.M.