MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; STOPCOCK, I.V. SET

Model Number MX5342L

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 03/28/2021

Event Type  Injury  

Event Description

It was reported that while the medex stopcock was in use with a patient, the patient's blood pressure dropped significantly from a map's of 70-80's down to 50's.The operator discovered that the pressor support medication (norepinephrine) was leaking out of the cracked stop cock.The operator did not have to give epinephrine as a result.The issue was resolved once the operator found the source of the damaged stop cock and moved the norepinephrine.No further complications were reported in relation to this event.

Manufacturer Narrative

Returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed, root cause could not be attributable to manufacturing site, the most likely root cause of the condition observed on returned samples indicate a possible mishandling of during use, as force is required to break the devices.Problem source was traced to user interface.Lot number was not provided therefore dhr review cannot be executed.

• Brand Name: MEDEX
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• MDR Report Key: 11724707
• MDR Text Key: 247278713
• Report Number: 3012307300-2021-03456
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688506764
• UDI-Public: 10351688506764
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MX5342L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening