NDEHP 3CLV YSTE MACR

Report

Report Number: 9613251-2014-00056
Event Type: Malfunction
Date Received: March 14, 2014
Date of Event: January 1, 2014
Report Date: February 14, 2014
Manufacturer: HOSPIRA, LTD
Product Code: FPA
PMA / PMN Number: K101677
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RECEIVED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED TUBING CUT WAS IDENTIFIED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. 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 A CUT; SUBSEQUENTLY, A LEAK WAS NOTED. AFTER THE TUBING SET WAS PRIMED WITH AN UNSPECIFIED SOLUTION, IT WAS REPORTED THAT THE TUBING OF THE TUBING SET WAS INSERTED INTO THE SHUTOFF SLOT OF THE CAIR CLAMP OF THE TUBING SET. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE TUBING WAS REMOVED FROM THE SHUTOFF SLOT. AT THIS TIME, IT REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM A CUT IN THE TUBING AT THE LOCATION WHERE THE TUBING HAD BEEN INSERTED INTO THE SHUTOFF SLOT. THE NURSE CLAMPED THE TUBING SET. NO SPECIFIED DETAILS WERE PROVIDED. THE TUBING SET WAS REPLACED. NO INFORMATION WAS PROVIDED IF THE LEAK OCCURRED DURING OR PRIOR TO PT USE; HOWEVER, THE CUSTOMER CONTACT INDICATED THERE WERE NO REPORTED DELAY OF THERAPY. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
154130	NDEHP 3CLV YSTE MACR	80FPA	FPA	HOSPIRA, LTD	NA	UNK4W

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK