MAUDE Adverse Event Report: ARGON MEDICAL DEVICES DOUBLE 4-WAY STOPCOCK W/ MALE LUER LOCK; STOPCOCKS

Model Number 041220001A

Device Problem Leak/Splash (1354)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/07/2021

Event Type  malfunction  

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 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.

• Brand Name: DOUBLE 4-WAY STOPCOCK W/ MALE LUER LOCK
• Type of Device: STOPCOCKS
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: gina liu ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 12061702
• MDR Text Key: 261530378
• Report Number: 0001625425-2021-01012
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00886333201440
• UDI-Public: 00886333201440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 041220001A
• Device Catalogue Number: 041220001A
• Device Lot Number: 11349914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other