BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLEENSPEC 590 SERIES DISP VAGINAL SPECULA

    MDR report key: 3040477 · Received March 13, 2013

    Report

    Report Number
    1316463-2013-00004
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    WELCH ALLYN
    Product Code
    HIB
    PMA / PMN Number
    K941272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WELCH ALLYN IS REPORTING THIS IN AN ABUNDANCE OF CAUTION. UNUSED PRODUCT WAS RETURNED FOR EVAL, HOWEVER, THE ACTUAL SPECULUM INVOLVED IN THE EVENT HAS BEEN DISPOSED OF BY THE CUSTOMER AND THEREFORE WILL NOT BE RETURNED TO WELCH ALLYN. HOWEVER, THE COMPLAINANT DID PROVIDE A PHOTOGRAPH OF THE BROKEN SPECULUM. THE FAILURE MODE AS DESCRIBED BY THE PICTURE HAS BEEN PREVIOUSLY INVESTIGATED. THIS DEVICE IS A MANUALLY INSERTED, DISPOSABLE VAGINAL SPECULUM. THE ROOT CAUSE OF THESE VERY RARE FAILURES WAS DETERMINED TO BE RELATED TO POTENTIAL IMPACTS OR LOADS ON THE SHIPPING CONTAINERS DURING TRANSIT OR STORAGE. NO FURTHER INVESTIGATION WILL BE PERFORMED. RESULT: VAGINAL SPECULUM). CONCLUSION: ACTUAL DEVICE NOT RETURNED CONFIRMED SHIPPING DAMAGE BY VISUAL EVAL. DEVICE MFR DATE: LOT # 183346 WAS MANUFACTURED 08/12/2013 - 08/19/2013; LOT # 185472 WAS MANUFACTURED 09/10/2013 - 09/17/2013.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AN ADD'L MEDIUM SIZED SPECULUM HAD BROKEN DURING A PROCEDURE. THE CUSTOMER STATES THAT LOWER BLADE HAD CRACKED. THE PT WAS UNINJURED. THE CUSTOMER DID NOT PROVIDE A PT IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106340 KLEENSPEC 590 SERIES DISP VAGINAL SPECULA HIB WELCH ALLYN 59001 183346, 185472

    Patients

    Seq Age Sex Outcome Treatment
    1