FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 3873025 · Received June 13, 2014

Report

Report Number: 1416980-2014-18939
Event Type: Malfunction
Date Received: June 13, 2014
Date of Event: May 21, 2014
Report Date: May 21, 2014
Manufacturer: BAXTER HEALTHCARE
Product Code: FPA
PMA / PMN Number: K832284
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER AND IS CURRENTLY AWAITING EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE ACTUAL USED SAMPLE WAS RECEIVED FOR ANALYSIS. SAMPLE EVALUATIONS (INCLUDING VISUAL INSPECTION AND PRESSURE TESTING) WERE PERFORMED TO THE RETURNED SAMPLE, WHICH IDENTIFIED LEAKS-SEPARATED THAT OCCURRED BETWEEN THE TUBING AND BUSHING; NO OTHER DEFECTS WERE OBSERVED. THE CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED FOR THE REPORTED LOT R13I27124 AND NO ISSUES OR DEVIATIONS RELATED TO THE DESCRIBED INCIDENT WERE NOTED. THE MANUFACTURING FACILITY HAS INITIATED CORRECTIVE AND PREVENTIVE ACTION (CAPA) FOR FURTHER INVESTIGATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A CLEARLINK NITROGLYCERIN SET LEAKED. THE REPORTER STATED THERE WAS A HOLE IN THE TUBING. THIS OCCURRED DURING INFUSION. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
350088	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE		R13I27124

Patients

Seq	Age	Sex	Outcome	Treatment
1