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

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	08/05/2024
Type of Reportable Event	Malfunction
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 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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: TOWEL: OR BLU 80/CS
• Common Device Name: OR TOWEL
• 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: 20086709
• Report Number: 1030451-2024-00019
• Device Sequence Number: 7664190
• Product Code: PUI
• UDI-Device Identifier: 50809160000418
• UDI-Public: 50809160000418
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 704-B
• Device Catalogue Number: 704-B
• Device Lot Number: 2404JK403B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown