MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CUSTOM DEFINED PRODUCT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number TC3709W_

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

Received one double dpt kit in original pouch.As received into lab, the pouch was opened at both top and bottom part of the sealing area.Traces which pouch film had been sealed to tyvek sheet was observed on both top and bottom part of sealing area.Both ends of the sealing area at the bottom part of the pouch were securely sealed.A part of tyvek sheet was found peeled off and transferred to the film at the bottom part of the pouch.The tyvek sheet seemed peeled from the outer to inner side of the pouch.A supplemental report of the device history report will be forthcoming when the results are completed.

Event Description

It was reported that the seal of the bottom side of the pouch was found opened.There were no patient complications reported.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specification at the time of release.

• Brand Name: CUSTOM DEFINED PRODUCT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5289645
• MDR Text Key: 33282983
• Report Number: 2015691-2015-03347
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

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 Model Number: TC3709W_
• Device Lot Number: FK1891MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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