MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 IRRIGATION FAST FLOW DISPOSABLES; FAST FLOW - IRRIGATION

Catalog Number	IR-500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.H3 - other: device has not been returned 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
Gcm received an email on 31-dec-2024 via service cloud from (b)(6) , a complaint coordinator from medline industries, lp on behalf of (b)(6).This is regarding an irrigation set 10/ca with list number ir-500 and lot number 6027260.Product was manufactured on 25-jun-2024 and will expire on 25-jun-2028 and has a purchase order number of 4517960583.It was stated in the report that their customer has had leaking issues with this product.Samples of the defective product are available for investigation.Status of the product at the time of the event was unknown.There was unknown patient involvement, but no patient harm/adverse event was being reported.Crasonable (b)(6) 2025.
Additional Manufacturer Narrative
No product sample was received; therefore, visual and functional testing could not be performed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: LEVEL 1 IRRIGATION FAST FLOW DISPOSABLES
• Common Device Name: FAST FLOW - IRRIGATION
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21191149
• Report Number: 9617604-2025-00073
• Device Sequence Number: 8795771
• Product Code: LGZ
• UDI-Device Identifier: 20695085450006
• UDI-Public: (01)20695085450006(17)280729(10)6027260
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072080
• 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
• Report Date (Section B): 04/14/2025

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: Other
• Device Catalogue Number: IR-500
• Device Lot Number: 6027260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown