MAUDE Adverse Event Report: MEDLINE INDUSTRIES (NAMIC DIVISION) - GLEN FALLS LOW PRESSURE THREE WAY STOPCOCK; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Lot Number (10) 21IBW181

Device Problems Device Slipped (1584); Connection Problem (2900)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/30/2023

Event Type  malfunction  

Event Description

Luer lock so loose the flush syringe (for adenosine) did not lock and fell off after being screw on when needed to flush post adenosine administration.This caused ed adenosine administration.

• Brand Name: LOW PRESSURE THREE WAY STOPCOCK
• Type of Device: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDLINE INDUSTRIES (NAMIC DIVISION) - GLEN FALLS
• MDR Report Key: 16887630
• MDR Text Key: 314869443
• Report Number: MW5117334
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: (10) 21IBW181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROTATING MALE COLLAR
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native