FDA Adverse Event Malfunction Summary report: N

ABBOCATH-T 20G 1-1/4

MDR report key: 2573182 · Received April 27, 2009

Report

Report Number: 3005515211-2009-00001
Event Type: Malfunction
Date Received: April 27, 2009
Date of Event: March 31, 2009
Report Date: April 2, 2009
Manufacturer: AMSINO MEDICAL CO., LTD
Product Code: FOZ
PMA / PMN Number: UNK
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER CONTACT INDICATED THE DEVICE WAS DISCARDED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT IS COMPARABLE TO THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A 80-FOZ COMMON DEVICE NAME AND HAS A K830765 510K. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED THE CATHETER SEPARATED FROM THE HUB. THE CATHETER WAS PLACED IN AN UNSPECIFIED VEIN OF THE HAND. THE NEEDLE WAS REMOVED FROM THE INSIDE OF THE CATHETER AND AN UNSPECIFIED 3-WAY DEVICE WAS CONNECTED TO THE CATHETER HUB. AN UNSPECIFIED SYRINGE WAS THEN CONNECTED TO THE 3-WAY DEVICE AND THE CATHETER WAS FLUSHED WITH SALINE. IT WAS REPORTED THAT DURING THE SALINE FLUSH, SALINE LEAKED AT THE INSERTION SITE OF THE CATHETER. THE NURSE STOPPED THE FLUSH. THE CUSTOMER CONTACT REPORTED THAT WHILE THE NURSE WAS REMOVING THE SYRINGE, THE CATHETER SEPARATED FROM THE HUB, LEAVING THE CATHETER IN THE PATIENT'S HAND. IT WAS REPORTED THAT THE NURSE REMOVED THE CATHETER. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ABBOCATH-T 20G 1-1/4	UNK	FOZ	AMSINO MEDICAL CO., LTD	NA	66201KY

Patients

Seq	Age	Sex	Outcome	Treatment
1				DICKINSON AND COMPANY\| UNSPECIFIED 3 WAY DEVICE, MANUFACTURED BY BECTON