MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FUILD WARMING GAS VENT; WARMER, THERMAL, INFUSION FLUID

Model 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	08/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device had a leak from the luer connector.No adverse effects reported.
Additional Manufacturer Narrative
Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated and the device passed all functional tests.Dhr review could not be completed as no lot number was provided.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).One sample was received in decontaminated conditions inside of plastic bag without its original packaging.During visual inspection, the sample was visually inspected under normal conditions of illumination according to the procedure.It was noticed that the female luer was broken and a portion of the luer remained inside the gas eliminator assembly, (per this we can confirm there is no problem with the manufacturing assembly solvent bonding operation) and the damage present in the sample was caused by an external force.The damage complaint is confirmed but not related to the manufacturing assembly process.The failure mode cannot be replicated; therefore the root cause is not attributable at the manufacturing process.No corrective action will be taken as the defect does not correspond to the manufacturing process.

• Brand Name: LEVEL 1 HOTLINE FUILD WARMING GAS VENT
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 3350 granada ave n; parque internacional; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 12650257
• Report Number: 3012307300-2021-10055
• Device Sequence Number: 14511253
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2023

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 Model Number: L-10
• Device Catalogue Number: L-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 01/17/2022; 04/25/2023
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 02/16/2022; 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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