FDA Adverse Event Malfunction Summary report: N

PREMILENE 6/0 (0.7) 45CM DSMP11 (M)

MDR report key: 8788912 · Received July 15, 2019

Report

Report Number: 3003639970-2019-00538
Event Type: Malfunction
Date Received: July 15, 2019
Date of Event: April 16, 2019
Report Date: July 15, 2019
Manufacturer: B.BRAUN SURGICAL SA
Product Code: GAW
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, (B)(4) MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K980703. SAMPLES RECEIVED: A PIECE OF THREAD WITHOUT PACKAGING. ANALYSIS AND RESULTS: AS NO BATCH NUMBER IS AVAILABLE, THE BATCH MANUFACTURING RECORD CANNOT BE REVIEWED. WE HAVE ONLY RECEIVED A THREAD (WITHOUT NEEDLE) WITHOUT PACK. HOWEVER, WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. FINAL CONCLUSION: IN SPITE OF RECEIVING A DEFECTIVE 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. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

Description of Event or Problem · 1

IT WAS REPORTED THE THREAD SEPARATED FROM THE NEEDLE. IT WAS REPORTED WHEN OPENING THE PACKAGE THE NEEDLE WAS DETACHED FROM THE THREAD. THE EVENT OCCURRED PRIOR TO USE. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
585396	PREMILENE 6/0 (0.7) 45CM DSMP11 (M)	OTHER SUTURE	GAW	B.BRAUN SURGICAL SA	C2090607

Patients

Seq	Age	Sex	Outcome	Treatment
1