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

Model Number MX448HFB

Device Problem Obstruction of Flow (2423)

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

Event Date 03/31/2023

Event Type  malfunction  

Event Description

It was reported that during infusion the iv pump was alarming occlusion.Clamps were open, line patent, and no kinks.Upon disconnecting the line there was "no flow".The customer changed the filter, and the line began to flow freely.The customer noted that the reported device was a substitute product, and it was "slightly smaller" than their usual filter and have since switched back to their original filter.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

No product was returned therefore device analysis could not be performed.A device history record (dhr) review showed there were no discrepancies observed during the manufacturing of the reported lot number.If the product is returned, the complaint will be re-opened for further investigation.

• Brand Name: MEDEX EXTENSION FILTER SETS
• Type of Device: FILTER, INFUSION LINE
• 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: 16872409
• MDR Text Key: 314592384
• Report Number: 3012307300-2023-05101
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• 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: 4355305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Female