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

Catalog Number	24370
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier, age or date of birth, sex, weight, ethnicity, race: patient information not available.Product has been discarded; therefore, not returned to 3m for analysis.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 3m¿ ranger¿ high flow warming set (model 24370) leaked during use at the base of the bubble trap.No patient or staff injury was alleged.

• Brand Name: 3M¿ RANGER¿ HIGH FLOW DISPOSABLE SET
• 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, 22444 ; MX 22444
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 14781745
• Report Number: 2110898-2022-00041
• Device Sequence Number: 6108474
• Product Code: BSB
• UDI-Device Identifier: 00707387781477
• UDI-Public: 00707387781477
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K973741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2022

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: 03/01/2025
• Device Catalogue Number: 24370
• Device Lot Number: HM9176
• 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: 06/17/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown