MAUDE Adverse Event Report: AV-TEMECULA-CT INDEFLATOR PLUS 30 INFLATION DEVICE; ACCESSORIES

Catalog Number	1000183
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The 2 additional stopcock devices are being filed under separate medwatch reports.
Event or Problem Description
Unused/sterile devices were returned for leak testing.Analysis of the returned sterile devices noted 3 of the stopcocks leaked during functional testing.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: a review of the lot history record revealed no non-conformances that would have contributed to the reported stopcock leak.Further assessment was performed and abbott vascular (av) identified a potential product deficiency related to the manufacture of the device.The issue will be addressed per internal operating procedures.Av will continue to trend the performance of these devices.

• Brand Name: INDEFLATOR PLUS 30 INFLATION DEVICE
• Common Device Name: ACCESSORIES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6939070
• Report Number: 2024168-2017-08128
• Device Sequence Number: 11048168
• Product Code: MAV
• UDI-Device Identifier: 08717648013584
• UDI-Public: 08717648013584
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K896849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: 03/31/2018
• Device Catalogue Number: 1000183
• Device Lot Number: 60054443
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2017
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1