MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "liquid leakage from the filter part." there was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3: date of event is unknown.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
H6.Investigation codes: updated.Investigation summary: one (1) sample was returned under part number l-10, l/n: 4414572 for evaluation with its original packaging, in decontaminated condition.The complaint sample was visually inspected, at 12¿ to 16¿ under normal conditions of illumination.No damage or other defects were detected on the sample.The sample was evaluated by introducing distilled water with a syringe to verify that the liquid flowed correctly.During the functional test a leak in the valve disc 00-126 was detected.The failure mode reported in the complaint " a0282 ¿ leaking¿ was confirmed.The root cause was not established.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMING GAS VENT ACCESSORY
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19458472
• Report Number: 3012307300-2024-04495
• Device Sequence Number: 6661380
• Product Code: LGZ
• UDI-Device Identifier: 10695085401001
• UDI-Public: (01)10695085401001(17)270719(10)4414572
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 4414572
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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