MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PRESSURE MONITORING MEDEX PRESSURE INFUSION C-FUSO; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number	MX4810
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Two (2) units were returned.Both units returned without the squeeze bulb assembly.One unit was received with the gauge assembly indicator needle reading approximately 350mmhg with zero pressure applied.The reported issue could not be confirmed without the squeeze bulb assembly and the bonded luer adaptor.The reported issue could not be confirmed.Each unit had a bulb assembly attached to test to see if the assembly inflates, holds pressure without leaking and the gauge indicator needle moves.Units inflated as required and gauge needle indicator needles moves freely.Root cause cannot be determined.No product information has been provided to date.This remediation mdr was generated under protocol(b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the bags were breaking very quickly and the inflating bulb was breaking off the stop and could not put it back on.No patient injury was reported.

• Brand Name: PRESSURE MONITORING MEDEX PRESSURE INFUSION C-FUSO
• Common Device Name: INFUSOR, PRESSURE, FOR I.V. BAGS
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15392983
• Report Number: 3012307300-2022-18332
• Device Sequence Number: 5056578
• Product Code: KZD
• UDI-Device Identifier: 50351688507004
• UDI-Public: 50351688507004
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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 Model Number: MX4810
• Device Catalogue Number: MX4810
• Device Lot Number: 3959829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2020
• 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