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

Catalog Number	MX448HFB
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use fluid was leaking from the connection between total parenteral nutrition filter and anti-siphon valve.Total parenteral nutrition per "interleukin" taken down and new clear fluid hung.No adverse patient effects were reported by the customer.
Additional 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.
Additional Manufacturer Narrative
Email is: (b)(6).H6 - evaluation codes: updated.Device evaluation: neither samples nor pictures were received for the analysis of this complaint.Visual and functional testing could not be performed.The reported issue could not be confirmed.No lot number was provided, therefore no device history report (dhr) review could be performed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: MEDEX EXTENSION FILTER SETS
• Common Device Name: 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: 18049674
• Report Number: 3012307300-2023-10129
• Device Sequence Number: 7468318
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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 Catalogue Number: MX448HFB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 02/14/2024
• 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