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

Model Number RC014T

Device Problems Device Markings/Labelling Problem (2911); Illegible Information (4050)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The subject device was not returned for evaluation.A definitive root cause could not be determined.The instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The instructions for use (ifu) has been reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Structural deterioration is listed as a potential adverse event in the ifu.Edwards will continue to review and monitor all events through the use of edwards quality systems.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No further corrective or preventative actions are required at this time.

Event Description

Edwards received information that the "use by" date was illegible on the carton box label.

Manufacturer Narrative

The product was received for evaluation and the report of "use by" date was illegible on the carton box label of the retrograde cannula" was confirmed.As received, the "use by" date on the brown shipper box label was incomplete and illegible.No other visual damage, contamination, or other abnormalities were found to the sealed sterile barrier pouch packaging and devices.A labeling defect was confirmed.The root cause was due to printing defect in the manufacturing process.The root cause investigation and corrective actions were initiated via edwards quality system.The device history record (dhr) was reviewed, and showed this device met all manufacturing specifications for product release prior to distribution.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: RETROGRADE CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7691733
• MDR Text Key: 114677041
• Report Number: 3008500478-2018-00075
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2018

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: 03/04/2021
• Device Model Number: RC014T
• Device Catalogue Number: RC014T
• Device Lot Number: 61282564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 09/19/2018; 07/23/2020
• Supplement Dates FDA Received: 09/19/2018; 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1