BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREP TRAY DRY SPONGE W/GLOVE

    MDR report key: 6339462 · Received February 17, 2017

    Report

    Report Number
    8030673-2017-00160
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    January 23, 2017
    Report Date
    March 15, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    OJU
    PMA / PMN Number
    D120879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - LOT NUMBER 965186 WAS PROVIDED AND A DHR WAS COMPLETED. NO ISSUES WERE FOUND RELATED TO FALLING APART CONDITIONS OF THE SPONGE. IN ADDITION, THE DEVICE HISTORY RECORD OF THE SUBASSEMBLY (SQUARE STICK SPONGE DRY PART NUMBER 74-671) WITH LOTS 2829929, 2829927 AND 2829928 WERE ALSO REVIEWED BY THE MANUFACTURING FACILITY AND NO NON CONFORMANCES WERE OBSERVED. ALL WELDING PARAMETERS WERE FOUND WITHIN SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4) NEITHER THE SAMPLE NOR A PHOTOGRAPH WAS RECEIVED FOR THE QUALITY ENGINEER¿S EVALUATION. THEREFORE, THE FAILURE MODE WAS UNABLE TO BE CONFIRMED. MASTER PRODUCTION RECORDS WERE REVIEWED FOR LOT AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THIS LOT. OUR RECORDS INDICATE THAT THE REVIEWED BATCH RECORD PASSED ALL OF THE IN-PROCESS INSPECTION. DURING MANUFACTURING OF PRODUCT ASSEMBLY AND PACKAGING, NO SPECIAL ISSUES WERE NOTED AND NO NCR WERE ISSUED TO THIS LOT NUMBER. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NO ISSUES RELATED TO THE FALLING APART CONDITION OF THE SPONGE WERE FOUND. DHR OF THE SUB-ASSEMBLY WAS ALSO REVIEWED AND NO NON-CONFORMANCES WERE FOUND. ALL WELDING PARAMETERS WERE FOUND WITHIN SPECIFICATION. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED DUE TO LACK OF SAMPLE. ALL INTERNAL MANUFACTURING PROCEDURES WERE ADHERED TO AND NO ISSUES WERE FOUND. THE FAILURE MODE WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED / TRENDED FOR ANY ADDITIONAL SIMILAR FAILURE MODES. (B)(4).

    Description of Event or Problem · 1

    (B)(4) INVOLVES "A FEMALE PATIENT WHO WAS HAVING A VAGINAL PREP FOR A HYSTEROSCOPY, DILATION AND CURETTAGE, AND ENDOMETRIAL ABLATION. DURING THE INTERNAL VAGINAL PREP, THE CIRCULATOR STATED SHE FELT A SLIGHT ¿POP¿ AND SHE SLOWLY BEGAN TO REMOVE THE SPONGE STICK FROM THE PATIENT¿S VAGINAL CANAL. SHE STATED THAT AS SHE ALMOST HAD THE SPONGE STICK REMOVED, THE SPONGE AGAIN CAME OFF OF THE END OF THE STICK. THE NURSE WAS ABLE TO VISUALIZE THE SPONGE AND REMOVE IT FROM THE PATIENT WITHOUT HAVING TO HAVE THE PHYSICIAN INTERVENE. THE SPONGE WAS REMOVED FROM THE PATIENT WITHOUT DIFFICULTY OR HARM TO THE PATIENT. THE PREP WAS CONTINUED AND COMPLETED WITHOUT FURTHER INCIDENT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124465 PREP TRAY DRY SPONGE W/GLOVE SKIN AND PREP TRAY OJU CAREFUSION, INC 4461A 0000965186

    Patients

    Seq Age Sex Outcome Treatment
    1