MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES WOUND KIT

Model Number	79350
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.A follow-up report will be provided upon conclusion of investigation.Medical action industries is the manufacturer of the convenience kit containing the complaint component, (b)(4) lots 2518r0643g and 2534r0634p purchased from specification developer, global instruments inc.(fda registration 1057200). 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
On (b)(6) 2026, the customer reported a hemostat broke after chest tube was removed.The hemostat was being used to clamp chest tube for removal.No patient injury, treatment, or delays occurred.The break happened after bedside chest tube removal, not during an emergency procedure.
Additional Manufacturer Narrative
Customer's photo and sample confirmed the reported failure.There is no inventory of the complaint kit or the instrument lots involved.The device history record was reviewed with no nonconformances during production of the complaint lot.No other complaints have been received for this kit or lot number.Supplier, global instruments, inc.Determined root cause: tool wear and alignment variation during manufacturing.Insufficient final functional inspection effectiveness.Assembly alignment variation.Corrective actions implemented: tooling inspection and recalibration.Enhanced functional inspections for jaw alignment, locking and gripping force.Reinforcement of inspection criteria with both quality assurance and production staff.Global instruments inc.Acknowledge the seriousness of the reported concerns and confirm this issue has been handled with top priority.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: WOUND KIT
• Common Device Name: WOUND KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): GLOBAL INSTRUMENTS INC.; 746 tucker road; ste 1; winder GA 30680
• Manufacturer Contact: nichole coggins ; 25 heywood road; arden, NC 28704 ; 8287820529
• MDR Report Key: 24616842
• Report Number: 1030451-2026-00003
• Device Sequence Number: 13155528
• Product Code: OVN
• UDI-Device Identifier: 20809160264093
• UDI-Public: 20809160264093
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• 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): 04/22/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 79350
• Device Catalogue Number: 79350
• Device Lot Number: 339269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/22/2026
• 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