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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient specifics are not available.Date of event is unknown.Initial reporters' occupation is unknown.3m has investigated and identified a manufacturing issue with the auto-venting bubble trap that introduces the risk of blood or fluid leaks while priming the sets and/or during fluid administration.There is no alleged injury to the patient or caregiver for this reported incident.3m has initiated a field safety corrective action for lots associated with this issue.3m has implemented a change to address the identified manufacturing issue and will continue to monitor.
Event or Problem Description
A 3m¿ ranger¿ high flow warming sets (model 24355) leaked.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 1000
• 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 55144-1000 ; 6514612670
• MDR Report Key: 15992451
• Report Number: 2110898-2022-00125
• Device Sequence Number: 17641115
• Product Code: BSB
• UDI-Device Identifier: 50707387781441
• UDI-Public: 00707387781446
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2022

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: 03/30/2024
• Device Catalogue Number: 24355
• Device Lot Number: HX8892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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