FDA Adverse Event Malfunction Summary report: N

NOVOSYN VIOLET 1 (4) 90CM HRT37S (M)

MDR report key: 8606077 · Received May 13, 2019

Report

Report Number: 3003639970-2019-00406
Event Type: Malfunction
Date Received: May 13, 2019
Report Date: May 13, 2019
Manufacturer: B.BRAUN SURGICAL SA
Product Code: GAM
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NO
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K122734. INVESTIGATION: SAMPLES RECEIVED: (B)(4) UNOPENED SAMPLES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. WE MANUFACTURED AND DISTRIBUTED (B)(4) UNITS OF THIS CODE BATCH, THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED (B)(4) CLOSED UNITS. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP):3.19 KGF IN AVERAGE AND 1.67 KGF IN MINIMUM (EP REQUIREMENTS: 1.83 KGF IN AVERAGE AND 0.61 KGF IN MINIMUM). A REVIEWED OF THE BATCH MANUFACTURING RECORD FOR THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE SUTURE DETACHED FROM THE NEEDLE DURING USE. NO OTHER INFORMATION HAS BEEN PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
399149	NOVOSYN VIOLET 1 (4) 90CM HRT37S (M)	SYNTHETIC ABSORBABLE BRAIDED S	GAM	B.BRAUN SURGICAL SA	C0068476	116134

Patients

Seq	Age	Sex	Outcome	Treatment
1