BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M4RT UNIVERSAL SWAB W/PT CARD KIT/100

    MDR report key: 2057174 · Received March 4, 2011

    Report

    Report Number
    1924669-2011-00001
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    January 23, 2011
    Report Date
    February 17, 2011
    Manufacturer
    REMEL, INC.
    Product Code
    JSM
    PMA / PMN Number
    K921472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE COMPONENT (THE SWAB) IS SUPPLIED COMPLETE BY A SUB-CONTRACTOR. THE SUB-CONTRACTOR FOR THIS LOT IS NO LONGER IN BUSINESS AND COULD NOT BE NOTIFIED OF THIS INCIDENT. THIS COMPONENT LOT HAS BEEN USED IN 19 DIFFERENT FINISHED GOOD LOTS, WITH NO OTHER REPORTED INCIDENTS. THE FINISHED GOOD LOT USED FOR THIS OCCURRENCE WAS PAST ITS EXPIRATION DATE (BY 4 MONTHS) AT THE TIME OF THIS INCIDENT.

    Description of Event or Problem · 1

    STAINLESS STEEL SHAFT MINI-TIP SWAB WAS USED TO COLLECT A URETHRAL SAMPLE FROM THE PATIENT. THE TIP OF THE SWAB WAS RETAINED IN THE PATIENT'S URETHRA. PATIENT RETURNED TO THE EMERGENCY ROOM ON (B)(6) 2011 AND WAS REFERRED TO A UROLOGIST FOR A CYSTOSCOPY PROCEDURE ON (B)(6) 2011. THE SWAB BUD WAS NOT RECOVERED AND IS ASSUMED TO HAVE PASSED NATURALLY. NO FURTHER FOLLOW UP TREATMENT IS NEEDED FOR THE PATIENT. PRODUCT LOT WAS PAST ITS EXPIRATION DATE AT THE TIME OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M4RT UNIVERSAL SWAB W/PT CARD KIT/100 M4-RT TRANSPORT MEDIUM JSM REMEL, INC. 754915

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention