BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAIN, FLAT, 7MMX4MM

    MDR report key: 163272 · Received April 16, 1998

    Report

    Report Number
    1423507-1998-00119
    Event Type
    Malfunction
    Date Received
    April 16, 1998
    Date of Event
    February 19, 1998
    Manufacturer
    ALLEGIANCE HEALTHCARE
    Product Code
    GCY
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE WAS NOT RECEIVED FOR EVALUATION. PLEASE BE ADVISED THAT WITHOUT THE PRODUCT SAMPLE CO IS UNABLE TO DETERMINE THE CAUSE OF THE BREAKAGE. HOWEVER, HISTORICAL EVALUATION OF BROKEN DRAINS USUALLY DETERMINES THE CAUSE TO BE A NICK OR PUNCTURE AT THE BREAK SITE. 11/17/98 SAMPLE WAS RECEIVED INTO THE WIDE-MOUTH PLASTIC JAR, INSIDE A BIOHAZARD LABELED ZIPLOCK BAG. VISUAL EXAMINATION SHOWED THAT IT WAS PART OF CAT. NO. SU130-1310 FLAT DRAIN. THE MOLDED LPS FLAT DRAIN SECTION SHOWED THAT IT WAS CUT AT APPROXIMATELY 5.00 INCHES FROM DRAIN/TUBING JUNCTION AREA. THE REMAINING FLAT DRAIN SECTION WAS NOT RECEIVED. VISUAL INSPECTION REVEALED CLEAR SILICONE TUBING BROKE AT APPROXIMATELY 0.50 INCH FROM DRAIN/TUBING JUNCTION AREA. THE REMAINING CLEAR TUBING SECTION WAS NOT RECEIVED. MICROSCOPIC EXAMINATION REVEALED WAVY/JAGGED EDGES AT THE TUBING FRACTURE SITE AND NO DISTORTION IN THE ADJACENT TUBING WHICH INDICATES THAT THE TUBING WAS NOT STRETCHED(ELONGATED) TO FAILURE. THE CHARACTERISTICS OF THE FRACTURED AREA AND THE ABSENCE OF ANY TUBING DISTORTION ARE SIMILAR TO THOSE FAILURES WHICH ARE CAUSED BY NICKS OR PUNCTURE BY A SHARP INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAIN, FLAT, 7MMX4MM JACKSON PRATT DRAIN GCY ALLEGIANCE HEALTHCARE SU130-1310 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention