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

Model Number MX448HFB

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 288400613
• Report Number: 3012307300-2022-05714
• Device Sequence Number: 1
• Product Code: FPB
• UDI-Device Identifier: 10351688507457
• UDI-Public: 10351688507457
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1