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

Catalog Number MX390

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation in progress.

Event 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.

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
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9119722
• MDR Text Key: 166646368
• Report Number: 3012307300-2019-05499
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 10351688507884
• UDI-Public: 10351688507884
• Combination Product (y/n): N
• PMA/PMN Number: K940896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1