MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC MEDEX; SYRINGE, BALLOON INFLATION

Catalog Number	MX390
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that the pointer on the pressure gauge failed to return to a value of zero due to an unspecified reason.It was also reported that at times the pointer registered a high value and suddenly dropped.The operator replaced the device after encountering the aforementioned product problems.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Additional information received indicating that both gauges on the device were not at zero.Two pictures were returned for evaluation indicating this.No product will be returned.

• Brand Name: MEDEX
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9119722
• Report Number: 3012307300-2019-05499
• Device Sequence Number: 2113194
• Product Code: MAV
• UDI-Device Identifier: 10351688507884
• UDI-Public: 10351688507884
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K940896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 11/05/2020
• Device Catalogue Number: MX390
• Device Lot Number: 3533705
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1