MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 60IN EXT SET W/0.22 MICRON FILTER 25/CA; FILTER, INFUSION LINE

Catalog Number	FS116
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event, d4: lot number, expiration date and h4: device manufacture date is unknown, no information has been provided to date.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.
Event or Problem Description
It was reported that the filter was leaking.Patient involvement unknown.
Additional Manufacturer Narrative
Supplemental generated to correct previous report 9616567-2024-00002-001 due date.Aware date should have been 1/18/2024 with due date of 2/17/2024.
Additional Manufacturer Narrative
One device was received for investigation.No damage or anomalies were observed with the device during visual inspection.The device was functionally tested, and no leakage was observed.No product lot number was provided, therefore, no review of manufacturing device history records could be conducted.Based on the results of the functional testing, the investigation could not confirm the reported issue.As a preventative measure, manufacturing personnel were notified of this complaint.

• Brand Name: 60IN EXT SET W/0.22 MICRON FILTER 25/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: 18457020
• Report Number: 9616567-2024-00001
• Device Sequence Number: 7210774
• Product Code: FPB
• UDI-Device Identifier: 10351688510969
• UDI-Public: 10351688510969
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2024

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 12/08/2023; 01/18/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 02/14/2024; 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown