MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX600F

Device Problem Expiration Date Error (2528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

It was reported that the device was expired.According to the label, the manufacturing date is 11-19-2014 and the expiration date is 11-18-2013.No patient complications were reported.

Manufacturer Narrative

Received one single dpt kit model px600f in sealed package.The label showed the manufacture date was november 2014 but the expiration date was november 2013.A an investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.A supplemental report will be submitted with the investigation and dhr results.

Manufacturer Narrative

An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specification at the time of release.Did not change the outcome of reportability.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4734532
• MDR Text Key: 5826722
• Report Number: 2015691-2015-00966
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PX600F
• Device Lot Number: 59910897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 04/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/01/2015; 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1