*

Report

• Report Number: 3062674
• Event Type: Malfunction
• Date Received: March 29, 2013
• Date of Event: March 27, 2013
• Report Date: March 29, 2013
• Product Code: ---
• Product Problem: Yes
• Report Source: User Facility report
• Reporter Location: MA, US
• Reporter Occupation: INVALID DATA

Narratives

Description of Event or Problem · 1

DURING THE PROCEDURE THE SURGEON REPORTED THAT THE NEEDLES ON THE PROLENE SUTURES HE WAS USING CONTINUED TO BECOME SEPARATED FROM THE SUTURE. AT THE TIME THESE SUTURES WERE BEING USED TO SEW A GRAFT ONTO THE AORTA. NO ADVERSE EVENT OCCURRED AS A RESULT OF THE FAILED SUTURE THIS TIME. TWO OF THE NEEDLES ARE BEING FORWARDED TO RISK MANAGEMENT. ALSO,ONE UNOPENED PACKAGE OF THE SAME SUTURE IS BEING SENT.THE SUTURE IS AS FOLLOWS: ETHICON 3-0 PROLENE SPECIAL ORDER #D5526.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
129639	*	*	---		*	*
129640	PROLENE	SUTURE	GAW	ETHICON, INC.	*	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	*

Terms

Patient problem · 1

• No Information

Product problems · 1

• Material Separation

Type of report · 1

• Initial submission