FDA Adverse Event Malfunction Summary report: N

CATGUT CHROMIC 3 (7) 50M

MDR report key: 8090318 · Received November 20, 2018

Report

Report Number: 3003639970-2018-00710
Event Type: Malfunction
Date Received: November 20, 2018
Report Date: November 20, 2018
Manufacturer: B. BRAUN SURGICAL SA
Product Code: GAL
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). 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. (SIMILAR DEVICE 510(K) - K991223). MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED - 1 OPEN AND USED CASSETTE. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE AND BATCH. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLE RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE (B)(6). THE BATCH MANUFACTURING RECORDS WERE REVIEWED, WHICH SHOWED THAT THIS PRODUCT WAS PRODUCED FOLLOWING NORMAL PROCESSES. FINAL CONCLUSION: ALTHOUGH THE SAMPLE RECEIVED FULFILLS THE SPECIFICATIONS OF EP AND B.BRAUN, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED IN THE FUTURE. NO CAPA REQUIRED.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE SUTURE BREAKS TOO EASILY. THE SUTURE WAS TO BE USED BY A VETERINARY PROFESSIONAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
930336	CATGUT CHROMIC 3 (7) 50M	CATGUT CHROM CASSETTES	GAL	B. BRAUN SURGICAL SA	F1154095	618165

Patients

Seq	Age	Sex	Outcome	Treatment
1