MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FLOTRAC SENSOR; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number MHD6

Device Problem Expiration Date Error (2528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

It was reported that during inbound inspection, the hospital detected the expiration date information on chinese label does not match the information on the english label.The expiration month and day have been switched.The hospital refused the shipment of the devices.As this was detected during inbound inspection, there was not any patient involvement.

Manufacturer Narrative

Additional manufacturer narrative: photos of the labeling issue have been provided and confirms that there is a discrepancy between the expiration dates listed.The device manufacturing records have been reviewed and there were no related non-conformances identified.An investigation is on-going to determine the root cause of the labeling issue.Any additional information learned regarding the event will be noted in a supplemental report.

• Brand Name: FLOTRAC SENSOR
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; 1 edwards way; ms: td 26; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4767175
• MDR Text Key: 5797586
• Report Number: 2015691-2015-01101
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K043065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2015

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 Expiration Date: 08/12/2016
• Device Model Number: MHD6
• Device Lot Number: 59839150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1