FDA Adverse Event Malfunction Summary report: N

MINICAP TRANSFER SET

MDR report key: 3930253 · Received July 11, 2014

Report

Report Number: 1416980-2014-22434
Event Type: Malfunction
Date Received: July 11, 2014
Report Date: April 27, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A SAMPLE ANALYSIS WAS PERFORMED. VISUAL INSPECTION AND FUNCTIONAL TESTING VERIFIED THE REPORTED PROBLEM, AND THE PRODUCT WAS FOUND TO NOT MEET SPECIFICATIONS RELATED TO THE REPORTED PROBLEM. THE DIRECT CAUSE WAS DETERMINED TO BE A LEAK BETWEEN THE DARK BLUE CONNECTOR AND THE CAP (EXCESS SOLVENT DARK BLUE CONNECTOR). A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS CURRENTLY UNDER EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS DISCOVERED DURING EVALUATION OF A RETURNED MINICAP TRANSFER SET THAT IT WAS LEAKING. THE DEVICE WAS RETURNED DUE TO EXCESS IODINE SOLUTION FOUND ON THE TRANSFER SET. AFTER THE REPLACEMENT OF THE TRANSFER SET, THE ISSUE OF TOO MUCH IODINE WAS REPORTED TO HAVE BEEN RESOLVED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
406491	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1				MINICAP