MINICAP TRANSFER SET

Report

Report Number: 1416980-2014-18177
Event Type: Malfunction
Date Received: June 6, 2014
Date of Event: May 14, 2014
Report Date: May 14, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K882498
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A PHOTOGRAPH OF THE DEVICE WAS RECEIVED FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. A SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. A LEAK TEST, CLAMP FUNCTION TEST, AND CLAMP FUNCTION TEST WERE PERFORMED WITH NO ISSUES NOTED. AN INTEGRITY OF SEAL TEST WAS PERFORMED WITH NO LEAK NOTED. THE INTERIOR DIAMETER OF THE PATIENT CONNECTOR WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION. THE REPORTED PROBLEM COULD NOT BE IDENTIFIED OR DUPLICATED VIA AN EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A MINICAP TRANSFER SET COULD NOT BE COMPLETED LOCKED, OR SECURELY CONNECTED, WITH A TITANIUM ADAPTOR. THIS OCCURRED DURING PATIENT USE. THE PATIENT STATED THAT THE ISSUE WAS RESOLVED WHEN THE TRANSFER SET WAS REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
332569	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME		H13J29038

Patients

Seq	Age	Sex	Outcome	Treatment
1				TITANIUM ADAPTOR