FDA Adverse Event Injury Summary report: N

MINICAP TRANSFER SET

MDR report key: 3831112 · Received May 23, 2014

Report

Report Number: 1416980-2014-16916
Event Type: Injury
Date Received: May 23, 2014
Date of Event: April 22, 2014
Report Date: May 1, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K882498
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: ID, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4)A BATCH REVIEW WILL BE PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER(S) H13K14046, H14A09029, H14A22089, AND H14A27021. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13K14046, H14A09029, H14A22089, AND H14A27021 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESSES. 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 THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE REPORTED EVENT. TREATMENT INFORMATION WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT YET RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 2.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
308611	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Hospitalization	EXTRANEAL VIAFLEX,\| HOMECHOICE, CASSETTE, DIANEAL PD4 AMBUFLEX