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

Model Number	MX5342L
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• MDR Report Key: 11724707
• Report Number: 3012307300-2021-03456
• Device Sequence Number: 11819956
• Product Code: FMG
• UDI-Device Identifier: 10351688506764
• UDI-Public: 10351688506764
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening