FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 2153772 · Received July 8, 2011

Report

Report Number: 6000001-2011-10823
Event Type: Malfunction
Date Received: July 8, 2011
Date of Event: January 26, 2011
Report Date: February 2, 2011
Manufacturer: BAXTER HEALTHCARE - MALTA
Product Code: FPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AN ACTUAL SAMPLE WAS SENT IN FOR AN EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND THE LUER CONNECTION OF THE SET WAS TESTED. THE ROTATING PART WAS PUSHED FORWARD TO BE POSITIONED BETWEEN THE TWO RINGS AND ATTACHED TO A STOPCOCK. THE LUER LOCK WAS TIGHTENED UNTIL ACTIVATED. THE LUER LOCK COULD BE DISCONNECTED WITHOUT ANY DIFFICULTIES. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT.

Description of Event or Problem · 1

A CUSTOMER REPORTED TO BAXTER (B)(6) OF AN ADMINISTRATION SET IN WHICH THE FACILITY COULD NOT DISCONNECT THE SET FROM THE PATIENT. THE HOSPITAL HAD TO USE FORCEPS TO GRIP THE COVER AND DISCONNECT THE SET. A PATIENT WAS INVOLVED BUT NO INJURY OCCURRED. THIS CONDITION OCCURRED DURING PATIENT-USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE - MALTA		10I18V792

Patients

Seq	Age	Sex	Outcome	Treatment
1