MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; INTRAVENOUS EXTENSION TUBING SET

Model Number MX450FL

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2021

Event Type  malfunction  

Event Description

It was reported that the end of the device has pulled off multiple times causing fluid including blood to be lost.

• Brand Name: MEDEX
• Type of Device: INTRAVENOUS EXTENSION TUBING SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12291323
• MDR Text Key: 265548171
• Report Number: 3012307300-2021-08160
• Device Sequence Number: 1
• Product Code: FPK
• UDI-Device Identifier: 10351688507334
• UDI-Public: 10351688507334
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX450FL
• Device Lot Number: 4072121
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2021
• 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: N
• Patient Sequence Number: 1