MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RANGER¿ FLUID WARMING SET, HIGH FLOW; HIGH FLOW DISPOSABLE TUBING

Catalog Number	24355
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient specifics are not available.Lot and expiration date is unknown.Manufacturer date is unknown.Device has not been returned; therefore, 3m is unable to verify the leak, identify exact location and root cause without the sample.3m will continue to monitor.
Event or Problem Description
A hospital alleged the inlet line came out of the second ringer's lactate bag after use of 3m¿ ranger¿ high flow warming set (model 24355).No patient or staff injury was alleged.No medical interventions were required.

• Brand Name: 3M¿ RANGER¿ FLUID WARMING SET, HIGH FLOW
• Common Device Name: HIGH FLOW DISPOSABLE TUBING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): NYPRO PRECISION ASSEMBLIES; sor juana ines de la cruz; cd. industrial; tijuana, tijuana baja california 22444 ; MX 22444
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6514612670
• MDR Report Key: 16179935
• Report Number: 2110898-2023-00016
• Device Sequence Number: 16809639
• Product Code: BSB
• UDI-Device Identifier: 00707387781446
• UDI-Public: 00707387781446
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K973741
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2023

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 Catalogue Number: 24355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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