MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 55OD 28ID; BIPOLAR SYSTEM

Catalog Number 71322055

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Code Available (3191)

Event Date 07/14/2015

Event Type  Injury  

Event Description

It was reported that the product that was implanted had passed it's expiration date.

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

Manufacturer Narrative

The associated complaint device was not returned.The product remains implanted.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.The integrity of the packaging and the expiration date should be inspected prior to implantation.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: TANDEM BIPOLAR COCR 55OD 28ID
• Type of Device: BIPOLAR SYSTEM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 4958212
• MDR Text Key: 6250472
• Report Number: 1020279-2015-00531
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Catalogue Number: 71322055
• Device Lot Number: 05DM14909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2005
• 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
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 97