MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX CLEAR-CUFF PRESSURE INFUSOR; FILTER, INFUSION LINE

Model Number	MX4810
Medical Device Problem Codes	Increase in Pressure (1491); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During investigation the visual inspection confirmed that: the gauge is in zero position and the product was assembled as per drawing specification.Also the functional test was performed on both samples.Product was inflated to 300mm hg and the c-fusor kept the pressure for 2 minutes.After the functional test the gauge dropped to zero position as expected.No fault found.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.
Event or Problem Description
It was reported that device is reading very high pressure, another device is reading very low.Devices failed during testing straight out of the box, no patient involvement.

• Brand Name: MEDEX CLEAR-CUFF PRESSURE INFUSOR
• Common Device Name: FILTER, INFUSION LINE
• 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: 15397523
• Report Number: 3012307300-2022-18479
• Device Sequence Number: 17407569
• Product Code: FPB
• UDI-Device Identifier: 50351688507004
• UDI-Public: 50351688507004
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K790314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2022

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: MX4810P1CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 09/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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