MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. STOPCOCK 4-WAY

Catalog Number	L4SNC
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	10/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that due to a cracked stop cock a sudden onset of critical hypotension was experienced [bp 50/30] with femoral pulse present.Norepinephrine infusion was increased and fluid bolus given.Right ij medial port stop cocked with two additional white stop cocks.Clear fluid drips noted from furthest stop cock port.Increased rate of norepinephrine needed due to the stop cock leaking more fluid.Checked for tightness and resecured with continued dripping noted.The stopcock was removed and saved for analysis.The stopcock was noted to have a visible crack in it.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed and the root cause is attributed to clinical use and excessive force during use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: STOPCOCK 4-WAY
• Common Device Name: STOPCOCK
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 12711711
• Report Number: 1721504-2021-00077
• Device Sequence Number: 1454036
• Product Code: DTL
• UDI-Device Identifier: 00884450007785
• UDI-Public: 884450007785
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2024
• Device Catalogue Number: L4SNC
• Device Lot Number: H2095138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown