MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. MEDEX STOPCOCK; STOPCOCK, I.V. SET

Catalog Number MX9342L

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problem Tachycardia (2095)

Event Date 09/01/2019

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical medex stopcock became disconnected from the patient's iv line, causing iv fluids and blood to leak.There was a reported delay in sedation and pain medication as a result of this disconnections.The patient's heart rate was observed to go from 170bpm to 190bpm.Sedation medication was given while the patient was waiting for the continuous sedation to work.There were no further reported adverse effects.

Manufacturer Narrative

The information below was not originally included in the follow up/supplemental report.Age, date of birth: 24 years, (b)(6) 1995.Sex: female.Weight: 126 lbs.

• Brand Name: MEDEX STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9252617
• MDR Text Key: 164184114
• Report Number: 3012307300-2019-05989
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688504166
• UDI-Public: 10351688504166
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX9342L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 24 YR
• Patient Weight: 57