MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX HI-FLOW 4-WAY STOPCOCK WITH SWIVEL MALE LUER LOCK; STOPCOCK, I.V. SET

Catalog Number MX9341L

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2023

Event Type  malfunction  

Event Description

It was reported that the manifold/stopcock that was infusing "propofol and levophed" was cracked and iv fluids were leaking into the bed.There was no patient harm reported.Device is not returning.The patient was reported to be "65 years and older".

Manufacturer Narrative

D4: lot number, expiration date and h4: manufacture date are unknown; no information has been provided to date.G5: 510k is blank, as the device code is exempt.H3 - other: device has not been returned to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: MEDEX HI-FLOW 4-WAY STOPCOCK WITH SWIVEL MALE LUER LOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18607877
• MDR Text Key: 334653298
• Report Number: 1526863-2024-00004
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688504173
• UDI-Public: (01)10351688504173
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX9341L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR