MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN SELECT II; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number 6248VAL

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that when the packaging around the box was opened, the inside sterile wrap around the valve was not sealed.The valve was not used.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the valve was returned.Analysis was performed and no anomalies were found.The analyst noted that the package was not returned, only received the 6248 valve.Visual inspection was performed for the valve, and confirmed that the valve was not used.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN SELECT II
• Type of Device: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7094466
• MDR Text Key: 94501221
• Report Number: 2182208-2017-02134
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00885074439860
• UDI-Public: 00885074439860
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K052459
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 6248VAL
• Device Catalogue Number: 6248VAL
• Device Lot Number: 33921714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• 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