FDA Adverse Event Injury Summary report: N

REDO SINGLE LUMEN TPN CATHETER SET

MDR report key: 2821351 · Received October 25, 2012

Report

Report Number: 1820334-2012-00488
Event Type: Injury
Date Received: October 25, 2012
Date of Event: September 7, 2012
Report Date: October 4, 2012
Manufacturer: COOK, INC.
Product Code: DQO
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). NO COMPLAINT DEVICE HAS BEEN RETURNED. QUALITY CONTROL (QC) CONFIRMS OVERALL CATHETER SURFACE IS CLEAN WITHOUT EXCESSIVE IMPERFECTIONS OR DAMAGE. THIS PRODUCT IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) WHICH INCLUDES CATHETER MAINTENANCE INSTRUCTIONS AND WARNINGS RELATED IMPEDED LUMEN FLOW AND THE USAGE OF POWER INJECTORS. WITH THE DEVICE NOT BEING RETURNED IT IS HARD TO DETERMINE THE ROOT CAUSE OF THE FAILURE, BUT IT IS POSSIBLE THAT THE PRODUCT WAS EXPOSED TO FORCES BEYOND ITS INTENDED DESIGN. PREVENTIVE ACTION HAS BEEN PREVIOUSLY ISSUED IN AN EFFORT TO ALLEVIATE/REDUCE THE OCCURRENCE OF THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL.

Description of Event or Problem · 1

DURING THE REFLECTION OF THE CATHETER 3FR, MADE BY COOK AND SUPPLIED TO HOSPITAL #1, IT BROKE IN THE HANDS OF THE NURSE WITHOUT ANY PARTICULAR REASON. RISK OF INFECTION AND AIR IN THE CATHETER. THE NURSE CLAMPED THE REMAINING END OF THE CATHETER WITH A FORCEPS AND SOME GAUZE. SHE THEN WARNED THE DOCTOR ON DUTY WHO CONTACTED THE SURGEON. IT WAS DECIDED TO TRANSFER THE PATIENT TO HOSPITAL #2 SO CATHETER COULD BE REPAIRED WITH A REPAIR KIT. BROKEN FRAGMENT WAS KEPT AT HOSPITAL #1. PATIENT OUTCOME WAS NOT PROVIDED BY THE REPORTER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	REDO SINGLE LUMEN TPN CATHETER SET	DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC	DQO	COOK, INC.	NA	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention