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

Model Number	MX450FL
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: INTRAVENOUS EXTENSION TUBING SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• MDR Report Key: 12291271
• Report Number: 3012307300-2021-08159
• Device Sequence Number: 19955901
• Product Code: FPK
• UDI-Device Identifier: 10351688507334
• UDI-Public: 10351688507334
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MX450FL
• Device Lot Number: 4072121
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1