MAUDE Adverse Event Report: CAREFUSION INC. CHROMA-LINE TAKA SUCTION TUBE

Model Number	U-0592
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
V.Mueller has 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.
Event or Problem Description
The user facility reported that before a procedure three suction tips of their chroma-line taka suction tube broke off at the handle.The procedure was completed successfully after a short delay.No report of injury.
Additional Manufacturer Narrative
A device from the lot subject of the event was returned to the supplier for evaluation.It was observed that the broken tube subject of the event was bent which can be indicative of excess force applied by the user during use.The ifu for the chroma-line taka suction tube states, "use of a device for a task other than what it is intended for will usually result in a damaged or broken device.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.Avoid mechanical shock or overstressing the devices.Close distal ends prior to insertion or removal through cannulas." a steris account manager offered in-service training regarding the proper use and operation of the chroma-line taka suction tube; however, the user facility declined.No additional issues have been reported.

• Brand Name: CHROMA-LINE TAKA SUCTION TUBE
• 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: 18914151
• Report Number: 1923569-2024-01005
• Device Sequence Number: 6886605
• Product Code: JOL
• UDI-Device Identifier: 10885403138416
• UDI-Public: 10885403138416
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/15/2024

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-0592
• Device Catalogue Number: U-0592
• Device Lot Number: L23XHE
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 09/05/2024
• 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