BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SABRATEK

    MDR report key: 167877 · Received May 14, 1998

    Report

    Report Number
    MW1013794
    Event Type
    Injury
    Date Received
    May 14, 1998
    Date of Event
    May 10, 1998
    Report Date
    May 14, 1998
    Manufacturer
    SABRATEK CORP.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR IS WRITING TO FOLLOW-UP ON REPORT OF MAY 14,1998 REGARDING THE ABOVE PRODUCT. SINCE THE TIME OF THE INITIAL REPORT, FACILITY HAS OBSERVED 4 ADDITIONAL EPISODES OF THE SAME PRODUCT FAILURE, CONSISTING OF EITHER A PARTIAL OR COMPLETE BREAK IN THE WHITE PLASTIC SPIKE. FORTUNATELY, FACILITY HAS NOT NOTED ANY MAJOR ADVERSE PATIENT OUTCOMES TO DATE (OTHER THAN PT INCONVENIENCE AND WASTE OF MEDICATION).MFR DATE: NOV,1997, LOT #: 242018-N4, MFR DATE: NOVEMBER, 1997, LOT #: 242018-N4, MFR DATE: DEC, 1997, LOT #: 000043- OM (10), MFR: DECEMBER, 1997, LOT #: 000043-OM (10). THE DEFECTIVE DEVICES HAVE BEEN RETURNED TO THE DISTRIBUTER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABRATEK INTRAVENOUS ADMINISTRATION SET FPA SABRATEK CORP. 6060 ADMINISTRATION SET 244164-NI, 242018-N4,(MORE)
    2 SABRATEK INTRAVENOUS ADMINISTRATION SET FPA SABRATEK CORP. 6060 ADMINISTRATION SET 242018-NY

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R 1. MCGAW PAB MIXING CONTAINER (150 ML NORMAL| SALINE.)| 3. SABRATEK HOMERUN PUMP.| 2. GANCICLOVIR 540 MG.