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

Model Number TRB24-REG

Device Problem Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 05/08/2023

Event Type  malfunction  

Event Description

Noted tr (terumo radial) band was not inflated, scant blood under band.New tr band used in their department.Confirmed 15cc was in band but working differently than other bands in the past.No resistance was met when attempting to deflate band.Cath lab came to assess band, 6cc was inflated into tr band.Pt stable."model: trb29-lrg; lot: 0000322343.".

• Brand Name: TR (TERUMO RADIAL) BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORP.; elkton MD 21921
• MDR Report Key: 16947718
• MDR Text Key: 315488861
• Report Number: MW5117599
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TRB24-REG
• Device Lot Number: 0000326994
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White