FDA Adverse Event Malfunction Summary report: N

MINICAP

MDR report key: 4003174 · Received August 12, 2014

Report

Report Number: 1416980-2014-26178
Event Type: Malfunction
Date Received: August 12, 2014
Date of Event: July 18, 2014
Report Date: July 18, 2014
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS MANUFACTURED BETWEEN THE DATES OF 04/08/2014 AND 04/11/2014. EVALUATION: 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 COMPANION SAMPLE WAS EVALUATED FOR THE REPORTED PROBLEM. A VISUAL INSPECTION WAS PERFORMED WITH IODINE NOTED. A PRESSURE TEST WAS PERFORMED ON THE POUCH OF THE DEVICE WITH NO ISSUES NOTED. THE REPORTED PROBLEM COULD NOT BE IDENTIFIED OR DUPLICATED DURING THE EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED AND EVALUATION IS UNDERWAY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE SPONGE OF THE MINICAP WAS DRIED OUT. THE CAREGIVER (CG) STATED THE ISSUE WAS NOTED UPON OPENING OF THE PACKAGING. THE CG STATED NO DEFECTS WERE NOTED WITH THE PACKAGING. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
478381	MINICAP	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	BAXTER HEALTHCARE - CLEVELAND		GD896837

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR