FDA Adverse Event Malfunction Summary report: N

VELOSORB FAST

MDR report key: 14605650 · Received June 6, 2022

Report

Report Number: 3006981798-2022-00011
Event Type: Malfunction
Date Received: June 6, 2022
Date of Event: May 2, 2022
Report Date: June 6, 2022
Manufacturer: RIVERPOINT MEDICAL LLC
Product Code: GAM
UDI-DI: 10884521151130
PMA / PMN Number: K100461
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DHR FOR THE LOT WAS PERFORMED AND NO ISSUES WERE NOTED DURING MANUFACTURING. RETAIN SAMPLES FROM THE SAME LOT WERE TESTED FOR FINISHED GOODS TESTING, INCLUDING TENSILE STRENGTH AND NEEDLE ATTACHMENT TESING. TEST RESULTS SHOW THAT ALL RETAINS PASSED. INVESTIGATIONS PERFORMED DID NOT REVEAL ANY ISSUES WITH THE PRODUCT AND THE REPORT COULD NOT BE SUBSTANTIATED. 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 PART 803. IF ADDITIONAL INFORMATION IS PROVDIDED 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, "DURING AN OPEN PROCEDURE, THE NEEDLE OF THE SUTURE DETACHED FROM THE THREAD AND FELL INTO PATIENT'S CAVITY. THE SURGERY WAS EXTENDED BY 30 MINUTES OR MORE TO FIND THE FALLEN NEEDLE BUT THEN IT WAS RETRIEVED AND PROCEDURE WAS COMPLETED. NO PATIENT INJURY."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2412213	VELOSORB FAST	BRAIDED FAST ABSORBABLE SUTURE	GAM	RIVERPOINT MEDICAL LLC	SV-494	21033003FX	10884521151130

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown