MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX 3-WAY STOPCOCK EXTENSION SET; TUBING, FLUID DELIVERY

Catalog Number MX43660

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2024

Event Type  Injury  

Event Description

It was reported that the extension tubing to arterial line broke off at patient end causing the tubing to disconnect from patient's arterial line.Registered nurse was present to immediately apply pressure at arterial catheter site even though they had some bleeding from catheter with disconnection.Loss of access and patient required a new arterial line insertion procedure.There was patient involvement and unknown patient harm/adverse event reported.

Manufacturer Narrative

H3: other; device not returned to manufacturer.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 3-WAY STOPCOCK EXTENSION SET
• Type of Device: TUBING, FLUID DELIVERY
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18983809
• MDR Text Key: 338659817
• Report Number: 9616567-2024-00052
• Device Sequence Number: 1
• Product Code: FPK
• UDI-Device Identifier: 10351688507563
• UDI-Public: (01)10351688507563(17)250627(10)4299681
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX43660
• Device Lot Number: 4299681
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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 Outcome(s): Required Intervention