BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT SHARPS CONTAINER

    MDR report key: 172053 · Received June 12, 1998

    Report

    Report Number
    1921846-1998-00016
    Event Type
    Malfunction
    Date Received
    June 12, 1998
    Report Date
    May 14, 1998
    Manufacturer
    CUSTOM MEDICAL PLASTICS, INC.
    Product Code
    MMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CO WAS INFORMED THAT THE PRODUCT WAS US PRODUCED ON 6/10/1998. EVALUATION OF THE TWO SHARPS CONTAINERS INVOLVED REVEALED THAT NEITHER CONTAINER HAD BEEN PENETRATED BY A SHARP. THE HOSP REP VOLUNTEERED THAT HE DID NOT BELIEVE THIS WAS A PRODUCT PROBLEM, BUT THAT EMPLOYEES MAY HAVE BEEN MANIPULATING THE CONTAINERS. TO AVOID FURTHER PROBLEMS ALL WARD PERSONNEL HAVE BEEN INSTRUCTED NOT TO MANIPULATE SHARPS CONTAINERS. CO IS CLOSING THIS COMPLAINT AS NOT A PRODUCT PROBLEM. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS IN ONE INSTANCE A NEEDLE PENETRATED THE WALL OF THE SHARPS CONTAINER, AND IN A SECOND CASE A SCALPEL BLADE PENETRATED THE CONTAINER. ONE NEEDLESTICK WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT SHARPS CONTAINER SHARPS WASTE CONTAINER MMK CUSTOM MEDICAL PLASTICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN