FDA Adverse Event Injury Summary report: N

ABBOCATH-T 20G 2IN

MDR report key: 2196590 · Received July 21, 2011

Report

Report Number: 3005515211-2011-00003
Event Type: Injury
Date Received: July 21, 2011
Date of Event: June 24, 2011
Report Date: June 24, 2011
Manufacturer: AMSINO MEDICAL CO., LTD, CONTRACT MFR FOR HOSPIRA INC.
Product Code: FOZ
PMA / PMN Number: UNK
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 510K PREAMENDMENT. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED THE CATHETER SHEARED. IT WAS REPORTED THAT ON (B)(6) 2011 AT AN UNSPECIFIED TIME, THE CATHETER WAS SUCCESSFULLY INSERTED INTO THE PT AT AN UNSPECIFIED LOCATION. ON (B)(6) 2011 AT AN UNSPECIFIED TIME DURING REMOVAL OF THE CATHETER FROM THE PT, IT WAS REPORTED THAT "ONLY HALF CAME OUT." THE CUSTOMER CONTACT INDICATED THAT ON AN UNSPECIFIED DATE, THE PT UNDERWENT AN UNSPECIFIED SURGICAL PROCEDURE TO REMOVE THE REMAINING PORTION OF THE CATHETER FROM AN UNSPECIFIED LOCATION. AFTER THE SURGICAL PROCEDURE, THE PT WAS "FINE." THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ABBOCATH-T 20G 2IN	UNK	FOZ	AMSINO MEDICAL CO., LTD, CONTRACT MFR FOR HOSPIRA INC.	NA	UNKKY

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention