MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX ULTRA SMALL BORE EXTENSION SETS; FILTER, INFUSION LINE

Model Number	MX448HFB
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on medwatch (b)(4) iv lipid filter not allowing lipids to pass through from iv tubing into the filter.Changed filter with different lot number, and still did not work.No additional information.
Additional Manufacturer Narrative
Other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The leakage is related to a supplier issue.A dhr review was done and no issues related to the original issue were found.

• Brand Name: MEDEX ULTRA SMALL BORE EXTENSION SETS
• Common Device Name: FILTER, INFUSION LINE
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13977981
• Report Number: 3012307300-2022-05714
• Device Sequence Number: 20303766
• Product Code: FPB
• UDI-Device Identifier: 10351688507457
• UDI-Public: 10351688507457
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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 Expiration Date: 09/20/2024
• Device Model Number: MX448HFB
• Device Catalogue Number: MX448HFB
• Device Lot Number: 4178571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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