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

Catalog Number L4SNC

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/10/2021

Event Type  Injury  

Event 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.

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

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
• Type of Device: 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
• MDR Text Key: 281667492
• Report Number: 1721504-2021-00077
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00884450007785
• UDI-Public: 884450007785
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention