FDA Adverse Event Malfunction Summary report: N

SALVIN SURGIPOINT

MDR report key: 19966368 · Received August 12, 2024

Report

Report Number: 3006981798-2024-00042
Event Type: Malfunction
Date Received: August 12, 2024
Date of Event: August 6, 2024
Report Date: August 12, 2024
Manufacturer: RIVERPOINT MEDICAL LLC
Product Code: GAM
UDI-DI: 00810020081879
PMA / PMN Number: K100461
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE HAS NOT BEEN RETURNED. PRODUCTION RECORDS WERE REVIEWED. THERE WERE NO NONCONFORMITIES NOTED WITH THE LOT DURING PRODUCTION. ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE. THREE RETAINED SAMPLES FROM THE SAME LOT WERE USED TO PERFORM A TENSILE STRENGHT TEST. THE RETAINED SAMPLES USED FOR THE TEST MET REQUIREMENTS. THERE WAS NO EVIDENCE THAT TH DEVICE FAILED TO MEET SPECIFICATIONS, AND THE REPORT COULD NOT BE SUBSTANTIATED. 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, "THE CUSTOMER EXPERIENCING THE SUTURE AND NEEDLES SEPARATING WHEN TRYING TO USE."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2514440	SALVIN SURGIPOINT	(POLIGLECAPRONE 25) VIOLET MONOFILAMENT SUTURE	GAM	RIVERPOINT MEDICAL LLC	Q392	24030503	00810020081879

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown