FDA Adverse Event Malfunction Summary report: N

MAXBRAID SUTURE

MDR report key: 16585659 · Received March 21, 2023

Report

Report Number: 3006981798-2023-00011
Event Type: Malfunction
Date Received: March 21, 2023
Date of Event: February 3, 2023
Report Date: March 21, 2023
Manufacturer: RIVERPOINT MEDICAL LLC
Product Code: GAT
UDI-DI: 00810020081220
PMA / PMN Number: K190817
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND ALL PRODUCT MET FINISHED GOODS TESTING REQUIREMENTS INCLUDING POUCH SEAL STRENGTH FOR THE LOT PRIOR TO RELEASE. THE SUSPECTED DEVICE WAS RETURNED AND WAS TESTED FOR POUCH SEAL WIDTH AND THE SAMPLE PASSED. THE REPORT COULD NOT BE SUBSTANTIATED AND A CAUSE FOR THE EVENT CANNOT BE ESTABLISHED. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVERPOINT MEDICAL HAS FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY THE FDA.

Description of Event or Problem · 0

ACCORDING TO THE REPORTER, "I OPENED UP THE OUTER BOX FOR THE MAXBRAID SUTURE AND GAVE THE NURSE THE INNER PACKAGE TO OPEN ONTO THE STERILE FIELD. THE NURSE NOTICED THAT THE BACK END OF THE PEEL PACK FOR THE SUTURE WAS NOT SEALED."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
9232	MAXBRAID SUTURE	NON-ABSORBABLE, UHMWPE SUTURE	GAT	RIVERPOINT MEDICAL LLC	CM-0226N	19082773	00810020081220

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown