MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EZ GLIDE AORTIC DEVICE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number EZF24A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2013

Event Type  No Answer Provided  

Event Description

As reported that a box of ez glide aortic cannula, model number ezf24a was delivered at warehouse with water damage.The products inside the packaging were also damaged due to water.The sterile barrier was not opened, but the product have been wet.

Manufacturer Narrative

The packaging damage is currently under evaluation into root cause.

Manufacturer Narrative

It was reported by our colleagues in (b)(4)"a box of ezf24a was delivered at warehouse with water damage.The products inside the packaging were also damaged due to water.The sterile barrier was not opened, but the product have been wet." evaluation: the complaint that the shipping box was damaged was confirmed.However, there were no device non-conformities or labeling inadequacies identified during the investigation.The root cause was unable to be determined.It is highly unlikely that the product left the edwards production facility in the condition that it was received.Since the product was received upon arrival by the facility it is likely that they damaged it.Also, it is possible it was damaged during shipment.However without additional information it is not possible to determine exactly how it was damaged.Trends for this issue are in control and will continue to be monitored.Manufacturing records were reviewed and there were no related ncr's found.There will be no pra or capa initiated at this time.The trend for this complaint type is in control.The instructions for use, training and risk control measures are appropriate at this time.Trends will continue to be monitored on through the edwards quality system.

• Brand Name: EZ GLIDE AORTIC DEVICE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: walter wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 3547027
• MDR Text Key: 4116325
• Report Number: 3008500478-2014-00001
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EZF24A
• Device Lot Number: 59639023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/11/2013
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 12/11/2013
• Date Manufacturer Received: 12/11/2013
• Date Device Manufactured: 12/02/2013
• 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