FDA Adverse Event Malfunction Summary report: N

MONOSYN UNDYED 4/0 (1.5) 45CM HSMP15 (M)

MDR report key: 8870065 · Received August 7, 2019

Report

Report Number: 3003639970-2019-00580
Event Type: Malfunction
Date Received: August 7, 2019
Date of Event: July 19, 2019
Report Date: September 17, 2019
Manufacturer: B.BRAUN SURGICAL SA
Product Code: GAM
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 1 OPEN SAMPLE. ANALYSIS AND RESULTS: AS NO BATCH NUMBER IS PROVIDED, BATCH MANUFACTURING RECORD CAN NOT BE REVIEWED. WE HAVE RECEIVED AN OPEN AND CONTAMINATED SAMPLE (WITHOUT PACKAGING) WITH THE NEEDLE CONNECTED TO THREAD. HOWEVER, WITHOUT CLOSED SAMPLES AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CAN NOT BE PERFORMED. FINAL CONCLUSION: IN SPITE OF RECEIVING AN OPEN SAMPLE, WITHOUT CLOSED SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT.

Additional Manufacturer Narrative · 1

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. K011375. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE NEEDLE WAS COMING OFF. THE REPORTER INDICATED THAT THE NEEDLE COMES OFF THE THREAD. THIS EVENT OCCURRED BEFORE SURGERY. ADDITIONAL INFORMATION IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
665845	MONOSYN UNDYED 4/0 (1.5) 45CM HSMP15 (M)	SYNTHETIC ABSORBABLE MONOFILAR	GAM	B.BRAUN SURGICAL SA	C0023615

Patients

Seq	Age	Sex	Outcome	Treatment
1