MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; INTRAVASCULAR ADMINISTRATION SET

Model Number MX9341L

Device Problem Connection Problem (2900)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2021

Event Type  malfunction  

Event Description

It was reported that the stopcocks would not stay attached despite attempts to tighten them.They came loose when the patient was prone and the patient was not receiving nmba and sedation and the analgesic was not getting infused to the very ill patient.The patient also bled all over.

• Brand Name: MEDEX
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12686567
• MDR Text Key: 278081220
• Report Number: 3012307300-2021-10196
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688504173
• UDI-Public: 10351688504173
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX9341L
• Device Lot Number: 4118991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1