BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL - OR BLU 80/CS

    MDR report key: 19888329 · Received August 1, 2024

    Report

    Report Number
    1030451-2024-00018
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 11, 2024
    Report Date
    September 26, 2024
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    PUI
    UDI-DI
    50809160001361
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT OR TOWEL BLUE PART NUMBER V704-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

    THE COMPLAINT DETAILS WERE FORWARDED TO THE APPROPRIATE FUNCTIONAL AREA FOR INVESTIGATION AND ROOT CAUSE DETERMINATION. WE RECEIVED ONE PHOTO FROM THE CUSTOMER CONFIRMING THE CUSTOMER¿S OBSERVATION. AT THE TIME OF COMPLAINT RECEIPT, WE HAD NO INVENTORY OF THE COMPLAINT LOT FOR FURTHER ANALYSIS. A THREE-YEAR COMPLAINT REVIEW OF V704-B SHOWS NO PAST COMPLAINTS FOR THIS INCIDENT. THE COMPLAINT LOT HAS SHIPPED TO VARIOUS CUSTOMERS WITH NO ADDITIONAL REPORTS INVOLVING THIS TOWEL. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO OUR TOWEL SUPPLIER (B)(4). FOR THIS ISSUE. THE SUPPLIER 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. THE SUPPLIER HAS COMMUNICATED WITH THE STAFF CONCERNING LINT FOR HEIGHTENED AWARENESS. BASED ON THE INVESTIGATION AND TRENDING ANALYSIS, THE COMPLAINT APPEARS TO BE ISOLATED. THE REPORTED COMPLAINT HAS BEEN ENTERED IN OUR TRACKING AND TRENDING PROGRAM IN ORDER TO MONITOR FOR EMERGING TRENDS. 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

    INCIDENT WAS DISCOVERED DURING CARDIAC CATHETERIZATION. A LARGE BLUE FIBER WAS FOUND WRAPPED AROUND BURR TIP. THIS WAS DETECTED AFTER EQUIPMENT WAS USED ON PATIENT. TOWELS WERE PLACED OVER THE EQUIPMENT WHILE NOT IN USE. SYRINGES THAT WERE PLACED ON TOP OF THE TOWELS, HAD BLUE FIBERS ON THEIR OUTSIDE. THE SYRINGES WERE PLACED IN CLEAN WATER BOWL TO REFILL THEM, THIS RESULTED IN BLUE FIBERS OBSERVED IN THE CLEAN BOWL. NO PATIENT INJURY OR MEDICAL TREATMENT WAS REQUIRED AS A RESULT OF THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241596 TOWEL - OR BLU 80/CS OR TOWEL PUI MEDICAL ACTION INDUSTRIES V704-B 2402JK405A 50809160001361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown