BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT BLOOD COLLECTION NEEDLES

    MDR report key: 52887 · Received November 27, 1996

    Report

    Report Number
    1017768-1996-00010
    Event Type
    Malfunction
    Date Received
    November 27, 1996
    Report Date
    October 28, 1996
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING INDICATES THAT WHEN THE LABEL INSTRUCTIONS ARE FOLLOWED, FEW PLASTIC PIECES ARE GENERATED. ALSO, ANY PIECES THAT ARE GENERATED ARE DIRECTED AWAY FROM THE FACE OF THE USER (AND PATIENT). THE CUSTOMER REPORTED THEY WERE NOT USING THE PRODUCT ACCORDING TO PACKAGE INSTRUCTIONS WHEN THE INCIDENT OCCURRED. THE MFG PLANT HAS AN ONGOING PROGRAM TO IMPROVE THE HEAT SEAL CHARACTERISTICS OF BLOOD COLLECTION NEEDLES. REFERENCE MFR COMPLAINT #D96-10-255. SECTION D - LOT NUMBERS REPORTED BY THE CUSTOMER 24544, 241299, 241890.

    Description of Event or Problem · 1

    A SINGLE PIECE OF PLASTIC, APPROXIMATELY 2MM IN LENGTH, WAS REMOVED FROM THE INFERIOR CUL-DE-SAC OF HER LEFT EYE. SLIT LAMP EXAM WITH FLUORESCEIN STAINING FOUND NO CORNEAL DEFECTS. THE ASSOCIATE WAS RETURNED TO REGULAR CORNEAL DEFECTS. THE ASSOCIATE WAS RETURNED TO REGULAR DUTY. LATER THAT SAME DAY (7-26-96) THE ASSOCIATE WAS CONTINUING TO HAVE SOME PAIN IN HER LEFT EYE. SHE WAS SENT TO HEALTH CLINIC FOR FOLLOW-UP EXAMINATION. AGAINS, NO CORNEAL ABRASIONS OR FOREIGN BODIES WERE FOUND. THE ASSOCIATE WAS RETURNED TO REGULAR DUTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT BLOOD COLLECTION NEEDLES BLOOD COLLECTION NEEDLES JKA SHERWOOD DAVIS AND GECK NA SEE H-10

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN