MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX 4-WAY STOPCOCK; STOPCOCK I.V. SET

Catalog Number MX9341L

Device Problem Disconnection (1171)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 09/24/2023

Event Type  malfunction  

Event Description

It was reported that upon repositioning the patients arm, patient became "severely" hypotensive.Nurse noted stopcocks that were attached to "ij" had become unthreaded from each other leading to the patient not receiving levophed briefly.No serious harm was reported but had brief hypertension.

Manufacturer Narrative

Other text: 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 4-WAY STOPCOCK
• Type of Device: STOPCOCK I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18051497
• MDR Text Key: 327261768
• Report Number: 3012307300-2023-10151
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688504173
• UDI-Public: 10351688504173
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• 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: 4344394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male