FDA Adverse Event Malfunction Summary report: N

MINICAP

MDR report key: 3945145 · Received July 18, 2014

Report

Report Number: 1416980-2014-23391
Event Type: Malfunction
Date Received: July 18, 2014
Report Date: June 25, 2014
Manufacturer: BAXTER HEALTHCARE - CUERNAVACA
Product Code: KDI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MX
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS RECEIVED AND AN EVALUATION OF THE DEVICE WAS PERFORMED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A VISUAL INSPECTION WAS PERFORMED AND REVEALED THAT THE CORNER OF THE PACKAGE WAS OPEN. ADDITIONALLY IT WAS OBSERVED THAT THE CORRECT OUTLINE AND TRANSFER OF ADHESIVE WAS PRESENT ON THE PACKAGING. IT WAS CONCLUDED THAT THIS COMPLAINT IS NOT RELATED TO MANUFACTURING PROCESS OR PRODUCT SPECIFICATIONS. THE ISSUE WAS POTENTIALLY ASSOCIATED TO THE HANDLING BY THE PATIENT; HOWEVER, A DEFINITIVE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PACKAGING FOR A MINICAP WAS OPEN. THIS WAS OBSERVED BEFORE USE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 11 OF 13.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
423684	MINICAP	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	BAXTER HEALTHCARE - CUERNAVACA		M14B18A

Patients

Seq	Age	Sex	Outcome	Treatment
1