FDA Adverse Event Malfunction Summary report: N

MINICAP TRANSFER SET

MDR report key: 3863816 · Received June 10, 2014

Report

Report Number: 1416980-2014-18518
Event Type: Malfunction
Date Received: June 10, 2014
Date of Event: May 16, 2014
Report Date: May 16, 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 REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE UNOPENED DEVICE WAS RECEIVED FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. VISUAL AND MICROSCOPIC INSPECTION REVEALED LOOSE AND EMBEDDED PARTICULATE MATTER WITHIN THE DEVICE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A MINICAP EXTEND LIFE PD TRANSFER SET HAD A BLACK SPOT ON ITS TUBING AND OVERPOUCH. IT IS UNKNOWN WHETHER THE SPOT WAS WITHIN THE TUBING OR ON ITS SURFACE. THIS WAS NOTICED AS THE PACKAGING WAS BEING OPENED AND PRIOR TO PATIENT THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 5 OF 23.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
339159	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME		H13K01019

Patients

Seq	Age	Sex	Outcome	Treatment
1