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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES DOUBLE 4-WAY STOPCOCK W/ MALE LUER LOCK; STOPCOCKS
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ARGON MEDICAL DEVICES DOUBLE 4-WAY STOPCOCK W/ MALE LUER LOCK; STOPCOCKS Back to Search Results
Model Number 041220001A
Health Effect - Clinical Code Low Blood Pressure/ Hypotension (1914)
Date of Event 06/07/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Without such evidence to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.
 
Event or Problem Description
Uncontrolled leaking from stopcock.Stopcock was being used to infuse vasopressors.Patient¿s blood pressure dropped to 60s/40s and the nurse kept increasing the iv infusion rate not realizing the stopcock was leaking.Stopcock had to be replaced.
 
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Brand Name
DOUBLE 4-WAY STOPCOCK W/ MALE LUER LOCK
Common Device Name
STOPCOCKS
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
MDR Report Key12061702
Report Number0001625425-2021-01012
Device Sequence Number3490783
Product Code DTL
UDI-Device Identifier00886333201440
UDI-Public00886333201440
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K780271
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/24/2021
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 Health Professional
Device Expiration Date01/28/2026
Device Model Number041220001A
Device Catalogue Number041220001A
Device Lot Number11349914
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/07/2021
Initial Report FDA Received Date06/24/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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