BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL: OR BLU 80/CS

    MDR report key: 20086709 · Received August 28, 2024

    Report

    Report Number
    1030451-2024-00019
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 5, 2024
    Report Date
    November 27, 2024
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    PUI
    UDI-DI
    50809160000418
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT OR TOWEL BLUE PART NUMBER 704-B IS MANUFACTURED BY JIANERKANG MEDICAL CO., LTD. (FDA REGISTRATION 9616874). A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE SUPPLIER. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    A PHOTO WAS RECEIVED CONFIRMING THE CUSTOMER¿S OBSERVATION. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ON AUGUST 9, 2024, AUGUST 13, 2024, AND AUGUST 15, 2024, FROM THE CUSTOMER. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. AT THE TIME OF COMPLAINT RECEIPT, WE HAD NO INVENTORY OF THE COMPLAINT LOT FOR FURTHER ANALYSIS. THE COMPLAINT LOT HAS SHIPPED TO VARIOUS CUSTOMERS WITH NO ADDITIONAL REPORTS AT THIS TIME. THE SUPPLIER, (B)(6). HAS PROCESSES IN PLACE TO LIMIT LINT PRESENCE AS MUCH AS POSSIBLE GIVEN THE COTTON FIBER CONSTRUCTION. EXCESS LINT MAY HAVE BEEN MISSED DURING THE INSPECTION PROCESS WHICH OCCURS DURING THE FOLDING PROCESS. (B)(6)., LTD. HAS COMMUNICATED WITH THE STAFF ABOUT LINT REMOVAL FOR HEIGHTENED AWARENESS. BASED ON TRENDING ANALYSIS, THE COMPLAINT APPEARS TO BE MORE ISOLATED THAN WIDESPREAD ISSUE. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE PRODUCT IS SHEDDING AND LEAVING FIBERS ON THE HEPARINIZED SALINE BOWLS AND THE STERILE TABLE. THESE FIBERS GET CAUGHT ON WIRES AND CATHETERS AND CAN POTENTIALLY ENTER THE VESSELS WHERE THE CATHETERS AND WIRES NEED TO GO THROUGH. ADDITIONAL QUESTIONS REGARDING PATIENT IMPACT AND INCIDENT WERE ASKED ON (B)(6) 2024. NO FURTHER DETAILS HAVE BEEN PROVIDED TO-DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191594 TOWEL: OR BLU 80/CS OR TOWEL PUI MEDICAL ACTION INDUSTRIES 704-B 2404JK403B 50809160000418

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown