MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ MEDFLATOR®II INFLATION SYRINGE SYSTEM; SYRINGE, BALLOON INFLATION

Catalog Number	MX1390
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that this syringe inflation system exhibited leakage.No adverse patient effects were reported.
Additional Manufacturer Narrative
One portion of a guidewire component was returned for evaluation.No leak investigation completed on this returned part as it is used to hold guide wire in place only during use.The partial component that has been returned meets specification per drawing.

• Brand Name: MEDEX¿ MEDFLATOR®II INFLATION SYRINGE SYSTEM
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7335085
• Report Number: 3012307300-2018-00586
• Device Sequence Number: 1248487
• Product Code: MAV
• UDI-Device Identifier: 10351688510020
• UDI-Public: 10351688510020
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K940896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

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: No Information
• Device Expiration Date: 10/20/2018
• Device Catalogue Number: MX1390
• Device Lot Number: 3078281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1