MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX IV FILTER EXTENSION SET 25/CA25/CA; FILTER, INFUSION LINE

Catalog Number	FS116
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that fluid leaks out of the tubing during iv infusion.There was patient involvement and unknown patient harm reported.
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
H3 and h6.Evaluation codes: updated.Through device analysis the complaint was verified.During visual inspection it was observed that the three (3) returned samples exhibited lack of solvent between the bonding union of tube and filter.A suspected root cause was lack of solvent during manufacturing/assembly.Awareness for the failure mode was given to personnel who perform the assembly process.The complaint fault has been escalated to address a full root cause investigation.A device history record (dhr) review reported no discrepancies or non-conformance's during the manufacturing of the reported lot number.

• Brand Name: MEDEX IV FILTER EXTENSION SET 25/CA25/CA
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19584407
• Report Number: 9616567-2024-00093
• Device Sequence Number: 15285344
• Product Code: FPB
• UDI-Device Identifier: 10351688510969
• UDI-Public: (01)10351688510969(17)270301(10)4462861
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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: FS116
• Device Lot Number: 4462861
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 9 MO
• Patient Sex: Unknown
• Patient Weight: 9 KG