MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 FLUID WARMING ACCESSORIES; WARMER, THERMAL, INFUSION FLUID

Model Number	L-10
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Month and year of event have been provided, day is unknown.One (1) used decontaminated sample was received with its original packaging open, decontaminated, inside in a plastic bag and in before use condition.The sample was visually inspected at a distance of 12 to 16 inches under normal conditions of illumination.The female luer connector broken, no other analysis performed since complaint was confirmed.The most probable root cause is that the blue clip was broken during or after packing operation, caused by a hit in the component during handling.A device history record (dhr) review reported no discrepancies during the manufacturing of the reported lot number.Awareness was made to production personnel by the quality engineer to reinforce the inspection for luer connector broken.
Event or Problem Description
It was reported that during the pre-use check, the connector was found damaged.No patient injury or clinical affects was reported.No additional information is available for this complaint.

• Brand Name: LEVEL 1 FLUID WARMING ACCESSORIES
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16582995
• Report Number: 3012307300-2023-02783
• Device Sequence Number: 17317119
• 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
• Report Date (Section B): 03/21/2023

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 Expiration Date: 04/25/2026
• Device Model Number: L-10
• Device Catalogue Number: L-10
• Device Lot Number: 4278455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown