MAUDE Adverse Event Report: EDWARDS LIFESCIENCES QUICKDRAW VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number QD22

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation is pending.A supplemental mdr will be submitted when evaluation is complete.

Event Description

Edwards received information that the packaging of a cannula was improperly sealed.The customer reported that the cannula fell on the floor due to no seal.A second cannula was used with no problems.

Manufacturer Narrative

Device evaluated by manufacturer: report of improper seal was confirmed.As received, returned device packaging was very crinkled with multiple kinks on the individual components of the returned cannula.Returned pouch packaging was found torn opened on one end (connector end).The other end of the pouch packaging where a sealed end should exist was found missing and possibly cut off since returned device pouch packaging was observed to be overall shorter when compared with lab sample.No other visual damage, contamination, or other abnormalities were found on product.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.Further assessment is being conducted.A supplemental will be submitted when assessment is complete.

Manufacturer Narrative

After further assessment, a manufacturing deficiency was not identified.A definitive root cause cannot be determined.Manufacturing records were reviewed and this device passed all manufacturing inspections prior to release for distribution.The complaint trend was assessed and it was found to be in control.No further corrective or preventative actions are required at this time.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: QUICKDRAW VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: trushala nerurkar ; 1 edwards way; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6283934
• MDR Text Key: 65974490
• Report Number: 3008500478-2017-00005
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2017

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: 05/05/2018
• Device Model Number: QD22
• Device Lot Number: 60433943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2017
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/22/2017; 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2016
• 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