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).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 referenced, 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).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: 6939092
• Report Number: 2024168-2017-08129
• Device Sequence Number: 19118040
• 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