FDA Adverse Event Malfunction Summary report: N

LACERATION KIT

MDR report key: 24617399 · Received March 17, 2026

Report

Report Number: 1030451-2026-00006
Event Type: Malfunction
Date Received: March 17, 2026
Date of Event: February 13, 2026
Report Date: April 17, 2026
Manufacturer: MEDICAL ACTION INDUSTRIES
Product Code: OVN
UDI-DI: 40612479182361
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

INCIDENT THREE 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, R0598, 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.

Description of Event or Problem · 0

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 CLAMPEDON 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 PROCEDUREINVOLVED DURING CATHETER REMOVAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
682267	LACERATION KIT	LACERATION KIT	OVN	MEDICAL ACTION INDUSTRIES	25-2748	329680	40612479182361

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown