MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION TR BAND; CLAMP, VASCULAR

Model Number	TRB29-LRG-01
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: manager.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
Terumo medical corporation received the following reported information: tr band was placed on the patient's wrist per protocol.The tr band began deflating after it was placed.An attempt was made to reinflate the tr band and it would not stay inflated.Pressure was held while a new tr band was placed successfully.The patient did well.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.Based on the evaluation of the returned sample this report is now deemed not reportable.One tr band and packaging label were returned to terumo medical corporation for assessment.The sample was subjected to visual analysis.No damage or deformities were noted on the band or balloon assembly.There is 11ml of air left in the band.The sample was subjected to leak testing.Approximately 18ml of air was injected into the band and submerged in a water bath for 30 seconds.No air bubbles were observed from the balloon assembly or check valve.The sample passed leak testing.The sample was subject to additional leak testing.15ml of air was injected into the band and the band was placed in its holder for 12-24 hours.After 12 hours, the air was removed and 14.5ml of air remained in the band.The sample passed additional leak testing.The check valve was deconstructed to check for damage or foreign matter.Upon deconstruction, no damage or deformities were noted.One tr band and packaging label were returned for assessment, and no failure was detected on the returned device.The sample passed all leak testing, and no damage or foreign matter was found in the check valve.The complaint cannot be confirmed for air leakage issues.The exact root cause cannot be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with terumo medical corporation specifications and procedures and the device was released in a conforming state.Currently, no action is recommended since the device was within manufacturing and design specifications when it was released from terumo medical corporation control.

• Brand Name: TR BAND
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 23617719
• Report Number: 1118880-2025-00167
• Device Sequence Number: 10090394
• Product Code: DXC
• UDI-Device Identifier: 00389701012476
• UDI-Public: (01)00389701012476(17)271001(10)0001072577
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K213531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: TRB29-LRG-01
• Device Catalogue Number: TRB29-LRG-01
• Device Lot Number: 0001072577
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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