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

Model Number	MX448HLMG
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: g5:510k and b3: date of event are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that the dopamine tubing was found leaking from the stopcock.It did not seem to be leaking above the stopcock, from the bag or from the syringe.The tubing seemed to be filled with bubbles and upon further inspection, the tubing was wet and the label on the tubing was saturated with fluid.The dopamine was actively running at 4mcg/kg/min and is unknown if the patient was getting the correct dose due to the leak.The patient had an arterial line and remained stable during the issue.
Additional Manufacturer Narrative
Device evaluation: no product was returned.No photographic or diagnostic evidence was provided by the customer.Complaint could not be confirmed for the failure mode reported as no sample or picture was provided for analysis by the customer.The device history record was reviewed and it was confirmed that no discrepancies were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and lots were released.If the device is later returned, the complaint will be reopened and an investigation will be completed.

• Brand Name: MEDEX
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 17310194
• Report Number: 3012307300-2023-07157
• Device Sequence Number: 7185091
• Product Code: FPA
• UDI-Device Identifier: 10351688507419
• UDI-Public: 10351688507419
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/28/2023

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: Other
• Device Expiration Date: 04/25/2025
• Device Model Number: MX448HLMG
• Device Catalogue Number: MX448HLMG
• Device Lot Number: 4277819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown