MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SET; WARMER, THERMAL, INFUSION FLUID

Catalog Number	L-70
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day 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.
Event or Problem Description
It was reported that fluid leaked when trying to give an infusion.After checking the appearance, a crack was found in the part where the infusion bag was connected.It is not clear whether it was originally cracked or when it was connected.No patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
One device was received without its original package, in used condition.Two photos were also received and reviewed.During visual inspection a crack was observed at the luer connector which could cause leakage.A functional leak test was performed and the device failed confirming the complaint.Based on the analysis of the returned unit and the review of the mitigation measures during the manufacturing process it was determined that the root cause of the leak is associated with the luer of sample being cracked, which causes leakage, the defect in the raw material could not be reproduced using the assembly process tools.The cause of the crack remains unknown.A device history record (dhr) review could not be performed as the lot number was unknown.

• Brand Name: LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SET
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20147990
• Report Number: 9617604-2024-00701
• Device Sequence Number: 8301399
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: (01)30695085407007
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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-70
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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