MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMING GAS VENT ACCESSORY; WARMER, THERMAL, INFUSION FLUID

Catalog Number	L-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while is use with a patient, there was a blood leak.The blood leakage occurred when the hotline gas vent was used.Adverse effects are unknown.
Additional Manufacturer Narrative
Other text: 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
Other: d4 udi (b)(4).Device evaluation: we received one sample for investigation.Visual and functional inspection performed; blood stains were identified on the product during visual inspection.During leak test no leaks were identified and device worked as expected.Customer's reported complaint not confirmed during investigation.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in sections g.1., please direct those to the following: (b)(6).

• Brand Name: LEVEL 1 HOTLINE FLUID WARMING GAS VENT ACCESSORY
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17837258
• Report Number: 3012307300-2023-09346
• Device Sequence Number: 7456962
• Product Code: LGZ
• UDI-Device Identifier: 40695085401002
• UDI-Public: 40695085401002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: L-10
• Device Lot Number: 4406206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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