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

Catalog Number	MX9342L
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9252617
• Report Number: 3012307300-2019-05989
• Device Sequence Number: 2030526
• Product Code: FMG
• UDI-Device Identifier: 10351688504166
• UDI-Public: 10351688504166
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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 Catalogue Number: MX9342L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 12/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 24 YR
• Patient Weight: 57