MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES LACERATION KIT

Model Number	25-2748
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Incident two: 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 2513r0598 and 2504r0598, 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
The customer reported the hemostat breaking while in use.There were no patient injury and no medical intervention required.The customer confirmed the instrument was clamped on the catheter when it broke while removing the catheter during routine procedure (not emergency procedure).There was delay of approximately a few minutes for each procedure involved during catheter removal.
Additional Manufacturer Narrative
Based on the device history record there were no nonconformances during production of the complaint lot.Inspection and release processes were followed.Based on those processes, the finished good was determined to be conforming at the time of commercial distribution.A 12 month review showed no significant trends for this issue or involving this kit or this instrument.Supplier (b)(4) root cause analysis identified the following root cause(s): tool wear and alignment variations during manufacturing whereby final inspection failed to detect issues.Global instruments inc.Implemented the following corrective actions: rework or rejection of non-conforming instruments, tooling inspection and recalibration, enhanced functional inspection of jaw alignment, locking, and gripping force, improved cleaning and surface verification prior to final inspection, reinforcement of inspection criteria with qa and production staff.This product incident is documented in the complaint database and identified as (b)(4).This information is submitted pursuant to 21 cfr 803, 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: LACERATION KIT
• Common Device Name: LACERATION 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: 24617375
• Report Number: 1030451-2026-00005
• Device Sequence Number: 9640512
• Product Code: OVN
• UDI-Device Identifier: 40612479182361
• UDI-Public: 40612479182361
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25-2748
• Device Catalogue Number: 25-2748
• Device Lot Number: 329680
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/17/2026
• 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