FDA Adverse Event Other Summary report: N

STIMULONG NANOLINE

MDR report key: 3093974 · Received April 30, 2013

Report

Report Number: 9611612-2013-00008
Event Type: Other
Date Received: April 30, 2013
Date of Event: April 4, 2013
Report Date: April 30, 2013
Manufacturer: PAJUNK GMBH MEDIZINTECHNOLOGIE
Product Code: CAZ
PMA / PMN Number: K033018
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

AT THIS POINT, NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD AND RELEVANT RAW MATERIAL HISTORY FILES DID NOT INDICATE RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. ANY FURTHER INFO WILL BE SENT IN TO FDA AS SOON AS IT BECOMES AVAILABLE. IF NO FURTHER INFO BECOMES AVAILABLE, PAJUNK CONSIDERS THIS FILE AS CLOSED.

Description of Event or Problem · 1

(B)(4). FROM USERS / INITIAL REPORTERS NARRATIVE: "PT HAD A POPLITEAL CATHETER PLACED ON (B)(6) 2013 BY THE ATTENDING ANESTHESIOLOGIST. THE PT WAS DISCHARGED HOME FROM THE HOSPITAL ON (B)(6) 2013 WITH THE CATHETER. THE HOMECARE SVC, R. N., REPORTED THE CATHETER HAD BROKEN IN HALF WITH THE WIRE COILED UP ON INSPECTION. THE CATHETER WAS THEN REMOVED (NO PARTS BROKE OFF INSIDE THE PT)."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
187262	STIMULONG NANOLINE	868.5150 ANESTHESIA CONDUCTION NEEDLE	CAZ	PAJUNK GMBH MEDIZINTECHNOLOGIE	521156-32A	975

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Other