MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; ANGIOGRAPHIC INJECTOR AND SYRINGE

Model Number MX390

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

It was reported that during use, the reaction of the pressure gauge lagged behind and the pressure value was inaccurate.

• Brand Name: MEDEX
• Type of Device: ANGIOGRAPHIC INJECTOR AND SYRINGE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13030261
• MDR Text Key: 282484091
• Report Number: 3012307300-2021-13013
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 10351688507884
• UDI-Public: 10351688507884
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K940896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX390
• Device Lot Number: 3812782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1