MAUDE Adverse Event Report: EDWARDS LIFESCIENCES RETROGRADE CANNULA; RETROGRADE CARDIOPLEGIA CANNULA

Model Number RC014T

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2013

Event Type  malfunction  

Event Description

It was reported by the edwards warehouse in japan that a torn pouch was found during incoming inspection.The sterile barrier appeared to have been breached.This was found during edwards jp incoming inspection and was not used on a patient or distributed to a customer.

Manufacturer Narrative

This compalint was reported via edwards (b)(4) warehouse.This event is under evaluation into root cause.

Manufacturer Narrative

Additional manufacturer narrative: method: device not available.The device was not returned for evaluation and no photos are available; therefore, the reported condition was unable to be confirmed.Manufacturing records were reviewed and there were no related manufacturing non-conformances identified.Based on the available information, root cause is unable to be determined definitively and a manufacturing defect is unable to be confirmed.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

• Brand Name: RETROGRADE CANNULA
• Type of Device: RETROGRADE CARDIOPLEGIA CANNULA
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCIES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: walt wiegan ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 3897996
• MDR Text Key: 4649200
• Report Number: 3008500478-2014-00091
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2013,06/26/2014

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: Other
• Device Expiration Date: 10/01/2016
• Device Model Number: RC014T
• Device Lot Number: 59625401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/02/2013
• Device Age: 2 MO
• Event Location: Other
• Date Report to Manufacturer: 12/02/2013
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 06/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2015
• Date Device Manufactured: 11/15/2013
• Patient Sequence Number: 1