FDA Adverse Event Malfunction Summary report: N

LS LF PRIMARY I.V. SET 120IN CONV 0.2MICR

MDR report key: 3171886 · Received June 7, 2013

Report

Report Number: 9613251-2013-00172
Event Type: Malfunction
Date Received: June 7, 2013
Date of Event: May 2, 2013
Report Date: May 10, 2013
Manufacturer: HOSPIRA LTD.
Product Code: FPA
PMA / PMN Number: K101677
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 DEVICE BREAKAGE OF THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO AN UNSPECIFIED FEMALE ADAPTER OF THE PATIENT'S PERIPHERAL I.V. ACCESS SITE AND WAS BEING USED TO DELIVER AN UNSPECIFIED MAINTENANCE SOLUTION, AT AN UNSPECIFIED RATE. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT WHEN THE NURSE DISCONNECTED THE OPTION-LOK MALE ADAPTER FROM THE FEMALE PORT, THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER BROKE OFF AND A PIECE OF THE OPTION-LOK MALE ADAPTER REMAINED LODGED INSIDE THE FEMALE PORT OF THE I.V. CATHETER. IT WAS REPORTED THAT THE PERIPHERAL I.V. ACCESS SITE WAS REPLACED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
253765	LS LF PRIMARY I.V. SET 120IN CONV 0.2MICR	80FPA	FPA	HOSPIRA LTD.	NA	251034W

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			DICKINSON AND COMPANY\| NEXIVA I.V. CATHETER: #(B)(4), MFG BY BECTON