MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SETS MULTI LINE WITH STOPCOCK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MX6812
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device lot number are unknown, no product 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 there was an emergency in the operating room, and blood could not pump through the extension tubing.They experienced leaking and were hard to connect to the insertion port.There has been no report of observable clinical symptoms or a change in symptoms, or adverse affects identified in the patient.
Additional Manufacturer Narrative
Other, other text: h6.Health impact, and evaluation codes: updated.No product was returned therefore device analysis could not be performed.A device history record (dhr) review could not be completed as the lot number was unknown.No action was taken and if the product is returned, the complaint will be re-opened for further investigation.

• Brand Name: MEDEX EXTENSION SETS MULTI LINE WITH STOPCOCK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16150634
• Report Number: 3012307300-2023-00417
• Device Sequence Number: 17991117
• Product Code: FPA
• UDI-Device Identifier: 10351688506054
• UDI-Public: 10351688506054
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: Health Professional
• Device Model Number: MX6812
• Device Catalogue Number: MX6812
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 06/18/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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