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

Model Number MX9311L

Device Problems Break (1069); Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 05/17/2020

Event Type  malfunction  

Event Description

Luer lock on high flow 3-way stopcock broke apart disconnecting inotropes and pressors from picc line.Manufacturer response for stopcock, medex (per site reporter).

• Brand Name: MEDEX
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10655206
• MDR Text Key: 210605024
• Report Number: 10655206
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2020,05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX9311L
• Device Catalogue Number: MX9311L
• Device Lot Number: 3943565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Weight: 89