FDA Adverse Event Malfunction Summary report: N

CATGUT PLAIN 3/0 (3) 75CM DS24

MDR report key: 3982742 · Received June 16, 2014

Report

Report Number: 2916714-2014-00457
Event Type: Malfunction
Date Received: June 16, 2014
Date of Event: May 5, 2014
Report Date: June 16, 2014
Manufacturer: B BRAUN SURGICAL S.A.
Product Code: GAL
PMA / PMN Number: K991223
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVAL:SAMPLES RECEIVED: WE RECEIVED 1 SUTURE OF CATGUT CHROM 5/0 (1.5) HR17 75CM IN CLOSED PACKAGING. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. NO UNITS IN OEM STOCK. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL OEM REQUIREMENTS. THE SAMPLES RECEIVED WERE SUBJECTED TO A VISUAL INSPECTION WHICH SHOWS THAT THE SUTURES ARE NOT STERILIZING SOLUTION, BECAUSE OF A FAILURE DURING THE MANUFACTURING PROCESS, WHICH CAN NOT BE IDENTIFIED AT THE TIME OF PRODUCT RELEASE, ONLY AFTER SOME TIME. FINAL CONCLUSION: THE COMPLAINT IS CORRESPONDING (JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: CORRECTIVE ACTION HAS BEEN IMPLEMENTED AND EFFECTIVENESS CHECKS COMPLETE.

Description of Event or Problem · 1

COUNTRY OF COMPLAINT: (B)(6). NO LIQUID IN CASSETTE

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
353309	CATGUT PLAIN 3/0 (3) 75CM DS24	SUTURE	GAL	B BRAUN SURGICAL S.A.	B560138	512032

Patients

Seq	Age	Sex	Outcome	Treatment
1