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

Model Number TRB24-REG

Device Problem Inflation Problem (1310)

Patient Problem Blood Loss (2597)

Event Date 10/30/2019

Event Type  malfunction  

Event Description

Patient received post-cardiac cath in holding unit with tr band in place, with no bleeding initially.On moving patient from stretcher to chair, insertion site beneath the tr band began to pulsatile bleed.Rn attempted to add 1-2cc of air into air bladder and bladder would not inflate.Rn immediately placed manual pressure on the catheter site and interventional md was called to holding unit to replaced tr band.Estimated blood loss 20cc.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 9401180
• MDR Text Key: 168837558
• Report Number: 9401180
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2019

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
• Device Operator: No Information
• Device Model Number: TRB24-REG
• Device Catalogue Number: TRB24-REG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2019
• Date Report to Manufacturer: 12/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA