FDA Adverse Event Malfunction Summary report: N

LOCKING TITANIUM ADAPTER

MDR report key: 7439689 · Received April 18, 2018

Report

Report Number: 1416980-2018-02227
Event Type: Malfunction
Date Received: April 18, 2018
Date of Event: March 20, 2018
Report Date: May 29, 2018
Manufacturer: BAXTER HEALTHCARE - SWINFORD
Product Code: KDJ
PMA / PMN Number: K894783
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CORRECTION TO (CATALOG NUMBER) AND (510K NUMBER): THE PRODUCT CODE WAS INCORRECTLY REPORTED AS 5C4129 WITH 510K NUMBER OF K152675 IN THE PREVIOUS SUBMISSION AND IS BEING CORRECTED TO PRODUCT CODE 5C4168 AND 510K NUMBER OF K894783. THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH NAKED EYE WITH NO ISSUES NOTED. THE REPORTED EVENT WAS NOT VERIFIED DURING EVALUATION AS THE DEVICE WAS DETERMINED TO MEET PRODUCT SPECIFICATIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A THERE WAS A SHEDDING ISSUE WITH THE TITANIUM ADAPTER, AND IT WAS CONFIRMED THAT THE TITANIUM ADAPTER DETACHED. THE REPORTED ISSUE WAS FOUND DURING USE. IT WAS REPORTED THAT THE TITANIUM ADAPTER HAD BEEN IN USE FOR TEN YEARS. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO ADVERSE EVENT OR PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
283329	LOCKING TITANIUM ADAPTER	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - SWINFORD	NA	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1				TRANSFER SET