MAUDE Adverse Event Report: EDWARDS LIFESCIENCES MONITORING AND INFUSION SETS; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number MIS001

Device Problem Device Packaging Compromised (2916)

Patient Problem Not Applicable (3189)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

It was reported by the warehouse in (b)(4) that an "unknown black fiber-like particulate was found inside the package during incoming inspection.".

Manufacturer Narrative

Additional manufacturing narrative: during visual analysis, the particulate appeared to extend through the entire width of the seal.The portion of the seal with the embedded fiber was examined using a digital microscope.The lateral view of the seal edge was assessed.The fiber was visible in this cross sectional view indicating that the fiber did extend through the entire width of the seal.The fiber measured 58 micrometers (0.058mm) in width.The full length of the fiber could not be visualized under the microscope; therefore, the length was estimated using a calibrated ruler and found to be approximately 25mm.The total area of the fiber was approximately 1.45 mm squared.Functional testing included peel testing to evaluate the pouch for seal strength.The pouch was peel-tested per the specifications.The seal strength was found to be conforming and unaffected by the presence of the fiber.The fiber was lost during the peel test and consequently no ftir analysis was able to be performed.Based on the individual appearance of the fiber, an analysis was run against the database to determine the possible composition.It was determined that the particulate was most likely a hair.Complaint observation was confirmed.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.The side seal in which the particulate was found was sealed at the supplier.This indicates the possible root cause was related to supplier processes.Quality indicator review revealed that this nonconformance was an isolated event.Product risk assessment determined the sterility of the device contained within the pouch could not be ensured; therefore, systemic infection or endocarditis may result if the device was used.Corrective actions are being addressed.Edwards will continue to review and monitor all events and if action is required, appropriate investigation will be performed.

• Brand Name: MONITORING AND INFUSION SETS
• Type of Device: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, 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: neil landry ; one edwards way ms mle-8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 4916430
• MDR Text Key: 6015066
• Report Number: 3008500478-2015-00044
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• PMA/PMN Number: K892377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Model Number: MIS001
• Device Lot Number: 59852933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2015
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2014
• 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