FDA Adverse Event Injury Summary report: N

RESOLVE NON-LOCKING DRAINAGE CATHETER

MDR report key: 2922351 · Received January 11, 2013

Report

Report Number: 1721504-2013-00011
Event Type: Injury
Date Received: January 11, 2013
Date of Event: December 13, 2012
Report Date: December 14, 2012
Manufacturer: MERIT MEDICAL SYSTEMS, INC.
Product Code: DQY
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE EVALUATION HAS NOT BEEN COMPLETED. THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED AS THE USER DID NOT PROVIDE A LOT NUMBER. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

Description of Event or Problem · 1

THE USER REPORTED THAT THE DEVICE WAS PLACED ON (B)(6) 2012 AS PART OF A MINI CHEST TUBE PROCEDURE TO TREAT A PNEUMOTHORAX. AFTER SEVERAL DAYS IN THE INTENSIVE CARE UNIT WITH NO IMPROVEMENT THE PHYSICIAN PERFORMED AN X-RAY ON THE PT ON (B)(6) 2012. THE X-RAY REVEALED THAT THE CATHETER HAD MIGRATED. UPON REMOVAL OF THE SUPERFICIAL DRESSING THE PHYSICIAN DISCOVERED THAT THE HUB OF THE DEVICE HAD SEPARATED FROM THE CATHETER. THE HUB WAS FOUND ON THE OUTSIDE OF THE SKIN APPROXIMATELY 1 INCH FROM THE SUPERFICIAL OPENING. A GENERAL SURGEON WAS CALLED IN TO PERFORM A CUT DOWN PROCEDURE TO REMOVE THE CATHETER. AFTER THE CUT DOWN WAS PERFORMED THE PT DEVELOPED ELEVATED BLOOD PRESSURE AND A LARGER CHEST TUBE WAS INSERTED. THE PT WAS SENT BACK TO THE INTENSIVE CARE UNIT FOR MONITORING. THE USER DID NOT PROVIDE A LOT NUMBER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
18974	RESOLVE NON-LOCKING DRAINAGE CATHETER	NONE	DQY	MERIT MEDICAL SYSTEMS, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R