FDA Adverse Event Malfunction Summary report: N

ABBOCATH-T 20G 1-1/4IN

MDR report key: 1899004 · Received October 15, 2010

Report

Report Number: 3005515211-2010-00004
Event Type: Malfunction
Date Received: October 15, 2010
Date of Event: August 18, 2010
Report Date: September 3, 2010
Manufacturer: AMSINO MEDICAL CO., LTD, CONTRACT MFR FOR HOSPIRA INC.
Product Code: FOZ
PMA / PMN Number: UNK
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER CONTACT INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FOZ AND IS PRE-AMENDMENT 510K. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL; (B)(4).

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED THE CATHETER SEPARATED. IT WAS REPORTED THAT THE CATHETER WAS PLACED IN THE PT'S SACRAL HIATUS TO DELIVER AN UNSPECIFIED MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT THE CATHETER "BROKE OFF/FRACTURED." REPORTEDLY UNSPECIFIED MEDICAL INTERVENTION WAS REQUIRED; HOWEVER, NO SPECIFIC DETAILS OF THE MEDICAL INTERVENTION WERE PROVIDED. THERE WAS NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL FOR THIS PT. ADDITIONAL INFO WAS REQUESTED, INCLUDING THE MEDICAL INTERVENTION PROVIDED AND THE PT OUTCOME. HOSPIRA IS CONTINUING TO INVESTIGATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ABBOCATH-T 20G 1-1/4IN	UNK	FOZ	AMSINO MEDICAL CO., LTD, CONTRACT MFR FOR HOSPIRA INC.	NA	65202KY

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK