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

Model Number	V704-B
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• 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 early ; 25 heywood road; arden, NC 28704 ; 8287820529
• MDR Report Key: 19888329
• Report Number: 1030451-2024-00018
• Device Sequence Number: 20782794
• Product Code: PUI
• UDI-Device Identifier: 50809160001361
• UDI-Public: 50809160001361
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: V704-B
• Device Catalogue Number: V704-B
• Device Lot Number: 2402JK405A
• Was Device Available for Evaluation?: No
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/26/2024
• 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