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

Model Number	TRB24-REG-01
Medical Device Problem Codes	Deflation Problem (1149); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy.A2: age & date of birth: requested, not provided due to hospital policy.A3a: sex: requested, not provided due to hospital policy.A4: weight: requested, not provided due to hospital policy.A5: ethnicity: not provided due to hospital policy.A6: race: not provided due to hospital policy.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: pacu rn.The complaint cannot be confirmed for air flow issues as the sample was not returned for investigation.Without a sample, the exact root cause cannot be determined.The device history record review determined the device was in a conforming state when released from terumo control.There are no indications manufacturing issues may have led to this event.No action is recommended since this risk evaluation is within the predetermined limits.
Event or Problem Description
Terumo medical corporation received the following reported information: when the tr band was applied, 16 ml's air was injected into the band.Within minutes when the pacu rn went to titrate air, there was no air in the back.The balloons deflated on their own.There was no harm to patient.It was unclear where the leak came from.Hemostasis was achieved only for a few minutes before the balloons started to deflate on their own.The blood loss was less than 250cc.They were unable to determine the leak location without the quality team.

• 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: 24886467
• Report Number: 1118880-2026-00099
• Device Sequence Number: 9942609
• Product Code: DXC
• UDI-Device Identifier: 00389701012476
• UDI-Public: (01)00389701012476(17)280601(10)0001472249
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

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: TRB24-REG-01
• Device Catalogue Number: TRB24-REG-01
• Device Lot Number: 0001472249
• 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: 03/20/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2025
• 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