BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM SPLITIMPERV SHEETS 60X70 115

    MDR report key: 19209969 · Received April 29, 2024

    Report

    Report Number
    3005997949-2024-00004
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    March 12, 2024
    Report Date
    June 11, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651793301
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE OR PHOTOS WERE PROVIDED FOR EVALUATION. THE NONCONFORMANCE DATABASE WAS REVIEWED, NO CONTRIBUTING NONCONFORMANCES WERE FOUND. THE REPORTER DID NOT PROVIDE A LOT NUMBER, THEREFORE THE SITE IS UNABLE TO PERFORM A DEVICE HISTORY RECORD REVIEW TO DETERMINE IF ANYTHING HAPPENED DURING THE LOT MANUFACTURE. PROVIDED THE LIMITED INFORMATION (NO LOT AND NO SAMPLES), IT'S DIFFICULT TO FURTHER EVALUATE AND IDENTIFY A ROOT CAUSE. THERE IS NO TREND FOR THIS ISSUE AND NO OTHER COMPLAINTS WHERE THE TAPE HAS UNATTACHED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803 AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE DEFECTIVE DRAPE HAD ADHESIVE THAT DID NOT STICK. WATER SEEPED THROUGH THE DRAPES ONTO THE PATIENT AND OVER THE SURGICAL FIELD. THE PATIENT WAS UNDERGOING AN ARTHROSCOPY PROCEDURE AT TIME OF OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305063 CUSTOM SPLITIMPERV SHEETS 60X70 115 SURGICAL DRAPES AND PACKS PUI O&M HALYARD, INC. 79330 UNKNOWN 30680651793301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown