MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; INTRAVASCULAR ADMINISTRATION SET

Model Number	MX9311L
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: no device was returned for investigation.No lot number provided so no dhr review could be done either.
Event or Problem Description
It was reported that there was a pinhole in the product making iv fluids leak.

• Brand Name: MEDEX
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• MDR Report Key: 12643313
• Report Number: 3012307300-2021-10021
• Device Sequence Number: 19193278
• Product Code: FMG
• UDI-Device Identifier: 10351688504180
• UDI-Public: 10351688504180
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 32172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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: MX9311L
• 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: 09/15/2021
• Initial Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1