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

Model Number TRB24-REG

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504); Defective Device (2588)

Patient Problem Hematoma (1884)

Event Date 05/11/2023

Event Type  malfunction  

Event Description

Tr (terumo radial) band for radial access malfunctioned and balloon would not blow up.Patient started developing hematoma in left radial.New tr band applied.Later discovered tr band had hole in the balloon.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORP.
• MDR Report Key: 17143456
• MDR Text Key: 317478186
• Report Number: MW5118427
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2015
• Device Model Number: TRB24-REG
• Device Catalogue Number: TRB24-REG
• Device Lot Number: 0000331755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male