MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES TOWEL: OR BLU 80 CS

Model Number	704-B
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An event occurred on september 24, 2024, that states product is leaving lint on open wounds.The doctor reported that the single-use or towels that are coming down from spd are not clinically acceptable as they are leaving lint and debris in the surgical wound.This incident may not be caught by surgeons or staff if they are not using a microscope.The doctor reported that under the microscope it looks like the wound is being covered in fur from these towels.There was no delay in surgery and irrigation was used to wash out the wound.
Additional Manufacturer Narrative
The product involved in this event was not returned for evaluation.The complaint or towel blue part number 704-b is manufactured by (b)(4) (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
A correction was made to the complaint lot number in suspect medical device section.Complaint lot number was initially reported as 2404jk403f; however, customer has indicated the incident involved three potential lot numbers including: 2404jk403f, 2405jk403b, and 2404jk403a.The supplier evaluated 2 packages (8 pieces) from each of the reported potential lot numbers.These samples were provided from medical action industries inventory as the customer did not have any samples available to provide.Opened the package for visual inspection of each and no abnormal linting was found on the surface of the product.A total of 24 samples from the three reported batches were tested for linting volume, the result was 0.28g, which met the standard requirement of maximum 0.38g/10 pieces.The sample photos were reviewed, no abnormal phenomenon of linting was found in the pictures.The material inspection records for the last 12 months were reviewed, the results were within the acceptance criteria.There are several manufacturing process steps taken to reduce linting presence, these include: 1.Dyeing process: the raw fabric is rolled and dried after dyeing utilizing an air suction device as an auxiliary process to reduce linting.2.Automatic sewing process: the sewing process also has an air suction device, which is an auxiliary process used to reduce linting.3.Folding process: before folding, the product goes through the suction process, the suction process is intended to remove loose linting on the surface of the product.A suction operation procedure is in place.Per the supplier, they reviewed the device history records of the complaint lots with no abnormalities noted during production/inspection of these lots.Based on the customer¿s photos and evaluation of the samples of returned product, the towels were within acceptance criteria; therefore, a root cause could not be confirmed.Supplier has processes in place to limit lint presence as much as possible given the cotton fiber construction and cannot be completely eliminated.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.

• Brand Name: TOWEL: OR BLU 80 CS
• Common Device Name: TOWEL: OR BLU 80 CS
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): JIANERKANG MEDICAL CO., LTD.; no.1, jianerkang road; zhixi town industrial zone jintan district; changzhou city jiangsu, china 21325 1; CH 213251
• Manufacturer Contact: nichole coggins ; 25 heywood road; arden, NC 28704 ; 8287820529
• MDR Report Key: 20474785
• Report Number: 1030451-2024-00020
• Device Sequence Number: 7519384
• Product Code: PUI
• UDI-Device Identifier: 50809160000418
• UDI-Public: 50809160000418
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 704-B
• Device Catalogue Number: 704-B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown