MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; CHROMA-LINE BRAND TAKA 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	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris requested the chroma-line brand taka suction tube subject of the reported event back for evaluation.The investigation of the event is currently in progress.A follow-up report will be submitted if additional information becomes available.
Event or Problem Description
The user facility reported via mw5174574 report that, "suction broke into two pieces while in use, both pieces retrieved." no report of injury.
Additional Manufacturer Narrative
Steris requested the chroma-line brand taka suction tube subject of the reported event back for evaluation however, the device was not returned.Without the return of the device the cause of the reported event could not be determined.As the user facility described the device breaking into two pieces in the reported event, the cause may be attributed to excessive force applied to the chroma-line brand taka suction tube during use.The device history record was reviewed and confirmed no abnormalities were noted.A complaint review was performed and confirmed the event to be isolated for the subject lot.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: CHROMA-LINE BRAND TAKA SUCTION TUBE
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23311355
• Report Number: 1527821-2025-00024
• Device Sequence Number: 14909713
• Product Code: JOL
• UDI-Device Identifier: 10885403138218
• UDI-Public: (01)10885403138218(10)K23XHE
• 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): 10/16/2025

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: U0552
• Device Lot Number: (10)K23XHE
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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