FDA Adverse Event Malfunction Summary report: N

INTERMATE

MDR report key: 3831116 · Received May 23, 2014

Report

Report Number: 1416980-2014-16923
Event Type: Malfunction
Date Received: May 23, 2014
Report Date: May 1, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: FRN
PMA / PMN Number: K910425
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A CAPA HAS BEEN OPENED TO ADDRESS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE LOT WAS MANUFACTURED FROM OCTOBER 28, 2013 TO OCTOBER 29, 2013. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE REPORTED CONDITION; THE DISTAL LUER LOCK AND ITS BLUE WINGED LUER CAP WERE FOUND TO BE MISSING FROM THE END OF THE TUBING. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED 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. THE CAUSE WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT AN INTERMATE HAD A MISSING CAP. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
308932	INTERMATE	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - IRVINE		13K071

Patients

Seq	Age	Sex	Outcome	Treatment
1