BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMEL SWAB PACK COMBO

    MDR report key: 900296 · Received November 3, 2004

    Report

    Report Number
    1924669-2004-00001
    Event Type
    Malfunction
    Date Received
    November 3, 2004
    Date of Event
    October 20, 2004
    Report Date
    November 2, 2004
    Manufacturer
    REMEL, INC.
    Product Code
    LIO
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE COMPONENT IS MFR FOR REMEL INC BY A SUB-CONTRACTOR. THE SUBCONTRACTOR HAS BEEN NOTIFIED OF THIS INCIDENT AND HAS PROVIDED REMEL INC WITH THE QC TESTING PROCEDURE FOR THE BOND BETWEEN THE SWAB TIP MATERIAL AND THE SWAB HANDLE. THE SUB-CONTRACTOR REPORTS THE STRENGTH OF THIS BOND IS MEASURED BOTH IN THE ASSEMBLY PROCESS AND AS PART OF THE FINAL BATCH QC TEST/RELEASE PROCEDURE. BOTH TEST ARE REPORTED TO HAVE BEEN SUCCESSFULLY COMPLETED FOR THE BATCH AT ISSUE AND THE BATCH WAS RELEASED ACCORDINGLY. THE AQL FOR THIS ATTRIBUTE, AS REPORTED BY THE SUB-CONTRACTOR IS, 0.04%. THIS PARTICULAR DEVICE WAS ONE OF A LOT THAT HAS BEEN IN THE DISTRIBUTION CHAIN SINCE 2004. THE RATE OF USAGE WOULD SUGGEST THIS LOT IS DEPLETED. THIS IS THE FIRST REPORT OF FAILURE OF SWABS MFR BY THIS SUB-CONTRACTOR. AS OF THIS TIME, THIS INCIDENT IS CONSIDERED TO BE AN ISOLATED OCCURRENCE.

    Description of Event or Problem · 1

    THE HOSP REPORTS THAT THE PT WAS UNDERGOING A NORMAL PROCEDURE FOR COLLECTION OF SPECIMEN SAMPLE FROM THE URETHRA/BLADDER. WHEN THE DEVICE (MALE SWAB) WAS REMOVED FROM THE PT, THE COTTON TIP OF THE SWAB SEPARATED FROM THE SWAB HANDLE AND WAS RETAINED IN THE PT'S URETHRA. THE PT SUBSEQUENTLY UNDERWENT A SUCCESSFUL URETROSCOPY TO REMOVE THE COTTON SWAB TIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMEL SWAB PACK COMBO SINGLE USE DISPOSABLE SAMPLE COLLECTION SWAB LIO REMEL, INC. * 8154

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization