MAUDE Adverse Event Report: CAREFUSION INC. V. MUELLER; SUCTION TUBE

Model Number	U-0572
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch mw5155061 that, "two pieces of taka suction came apart while in use, both retrieved, no harm to patient." no report of injury.
Additional Manufacturer Narrative
Steris requested the device subject of the reported event be returned for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The taka suction tube was returned to the supplier for evaluation.Evaluation results determined that excessive force was applied to the device.When the user applied excessive force at the connection of the tube and the handle, it caused the device to break as stated in the reported event.Steris performed in-service training on the proper use and operation of the taka suction tube, specifically the importance of not bending or applying excessive force while in use.The instructions for use states, "avoid mechanical shock or overstressing the devices." "prior to use, inspect devices to ensure proper function and condition.Do not use devices if they do not satisfactorily perform their intended function or if they have physical damage." the device history record was reviewed and confirmed the lot was manufactured according to specification; no abnormalities were noted.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: SUCTION TUBE
• Manufacturer (Section D): CAREFUSION INC.; 5 sunnen drive; maplewood MO 63143
• Manufacturer (Section G): CAREFUSION INC.; 5 sunnen drive; maplewood MO 63143
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19654688
• Report Number: 1923569-2024-01011
• Device Sequence Number: 17791107
• Product Code: JOL
• UDI-Device Identifier: 10885403138317
• UDI-Public: (01)10885403138317(10)A24XHE
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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 Model Number: U-0572
• Device Catalogue Number: U0572
• Device Lot Number: (10)A24XHE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown