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

Model Number	MX390
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3012307300-2023-04776
• Device Sequence Number: 6889119
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 04/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown