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

Model Number L-10

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 311685549
• Report Number: 3012307300-2023-02783
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 40695085401002
• UDI-Public: 40695085401002
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1