MINICAP TRANSFER SET

Report

Report Number: 1416980-2014-14522
Event Type: Injury
Date Received: May 5, 2014
Report Date: April 10, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K882498
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4): CATALOG NUMBER - THE PATIENT WAS PRESCRIBED THREE PRODUCT CODES FOR THIS PRODUCT. IT IS UNKNOWN WHICH PRODUCT CODE WAS IN USE AT THE TIME OF THE EVENT.A BATCH REVIEW WILL BE PERFORMED. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13I05039, H13I06037, H13H30047, H13K14046, AND H14A07064 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT REQUIRED HOSPITALIZATION. THE CAUSE AND TREATMENT FOR THE EVENT WERE UNKNOWN. AT THE TIME OF THIS REPORT, IT IS UNKNOWN IF THE PATIENT WAS RECOVERED FROM THE EVENT. ADDITIONAL INFORMATION IS NOT AVAILABLE. THIS IS REPORT 2 OF 2.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
267373	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization	DIANEAL, MINICAP