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

Model Number MX4810

Device Problems Increase in Pressure (1491); Pressure Problem (3012)

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

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 306075609
• Report Number: 3012307300-2022-18479
• Device Sequence Number: 1
• Product Code: FPB
• UDI-Device Identifier: 50351688507004
• UDI-Public: 50351688507004
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K790314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1