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

Model Number MX390

Device Problem Pressure Problem (3012)

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

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(6), as a result of warning letter (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No problems or issues were identified during this device history record review.

Event Description

It was reported that the pressure indication is wrong.The real pressure of the pressure pump cannot be predicted.No patient injury was reported.

• Brand Name: MEDEX MEDFLATOR INFLATION SYRINGE SYSTEMS
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16841277
• MDR Text Key: 314280597
• Report Number: 3012307300-2023-04776
• 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: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2023

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: Health Professional
• Device Expiration Date: 05/13/2022
• Device Model Number: MX390
• Device Catalogue Number: MX390
• Device Lot Number: 3812782
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 04/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1