MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SETS SINGLE; TUBING, FLUID DELIVERY

Model Number MX448HL

Device Problem Defective Device (2588)

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

Event Date 06/16/2021

Event Type  malfunction  

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.Sample was tested for functionality with water, fluid would not flow through device and complaint was confirmed.The root cause of the reported issue was found to be related to the extrusion process of the tubing.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.

Event Description

It was reported that fluid would not flow through tubing when administering fluid or medication.No patient injury was reported.

• Brand Name: MEDEX EXTENSION SETS SINGLE
• Type of Device: TUBING, FLUID DELIVERY
• 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: 15595390
• MDR Text Key: 306807479
• Report Number: 3012307300-2022-20027
• Device Sequence Number: 1
• Product Code: FPK
• UDI-Device Identifier: 10351688507440
• UDI-Public: 10351688507440
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2022

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
• Device Operator: Health Professional
• Device Model Number: MX448HL
• Device Catalogue Number: MX448HL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 10/13/2022
• 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