FDA Adverse Event Malfunction Summary report: N

MINICAP EXTEND LIFE PD TRANSFER SET - JAPAN

MDR report key: 1896792 · Received November 11, 2010

Report

Report Number: 1423500-2010-05593
Event Type: Malfunction
Date Received: November 11, 2010
Date of Event: October 21, 2010
Report Date: October 22, 2010
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE CUSTOMER REPORT OF A LOOSE CONNECTION BETWEEN THE PATIENT CONNECTION AND TITANIUM ADAPTER WAS NOT CONFIRMED DURING EVALUATION. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. RENAL QUALITY ENGINEERING WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

Additional Manufacturer Narrative · 1

(B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THE SAMPLE HAS BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

Description of Event or Problem · 1

THE CONNECTION BETWEEN THE PATIENT CONNECTOR AND THE CATHETER (TITANIUM) ADAPTER GOT LOOSE WHEN THE SET WAS CONNECTED TO THE CATHETER (TITANIUM) ADAPTER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE ACTUAL SAMPLE IS AVAILABLE FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MINICAP EXTEND LIFE PD TRANSFER SET - JAPAN	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME		H10D14092

Patients

Seq	Age	Sex	Outcome	Treatment
1