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

Model Number	6248VAL
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7094466
• Report Number: 2182208-2017-02134
• Device Sequence Number: 11100734
• Product Code: DTL
• UDI-Device Identifier: 00885074439860
• UDI-Public: 00885074439860
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K052459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1