MAUDE Adverse Event Report: STERIS CORPORATION V.MUELLER; SUCTION TUBE

Model Number	U-0552
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch mw5155197 that their chroma-line taka suction tube broke into 2 pieces before a patient procedure.No report of injury or procedure delay.
Additional Manufacturer Narrative
The chroma-line taka suction tube will be returned to steris for further evaluation.The investigation is currently in process.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The device was returned to the supplier for investigation.It was observed the broken tube subject of the event was bent which can be indicative of excess force applied by the user during use.The device history record for the subject lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.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 provided in-service training regarding the proper use and operation of the chroma-line taka suction tube.No additional issues have been reported.

• Brand Name: V.MUELLER
• Common Device Name: SUCTION TUBE
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS; 5960 heisley rd.; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 19730368
• Report Number: 1527821-2024-00005
• Device Sequence Number: 8129722
• Product Code: JOL
• UDI-Device Identifier: 10885403138218
• UDI-Public: (01)10885403138218(10)L23XHE
• 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): 07/12/2024

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-0552
• Device Catalogue Number: U-0552
• Device Lot Number: (10)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: 06/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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