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

Model Number TRB24-REG

Device Problem Defective Device (2588)

Patient Problems Hematoma (1884); Swelling/ Edema (4577)

Event Date 02/23/2021

Event Type  malfunction  

Event Description

Patient 1: tr band was removed from right radial at 0807 and hematoma formed about 5-10 minutes after sheath was removed.Doppler with 2mm occlusion hematoma increased to 8.5/ petechiae developed on right hand.Doctor aware and kept checking on patient.Pt eventually discharged with no further issue.Patient 2: same day, right radial access had 1-3 cm hematoma requiring hand held pressure due to tr band with pillow valve not holding air at 0810.Tr removed and transferred to huc at 0815 with 1 cm hematoma.Hand held pressure for 36 minutes.Rt hand swollen with petechiae after checking several tr bands, it is suspected that the black valve may be slowly releasing air rather than the staff removing it at designated intervals.All lot numbers with 0000005657 pulled for patient safety.This product had patient contact and minor temporary harm to patients involved.Manufacturer response for terumo tr band, (brand not provided) (per site reporter).Product picked up for evaluation.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 11588236
• MDR Text Key: 242931781
• Report Number: 11588236
• 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: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRB24-REG
• Device Catalogue Number: TRB24-REG
• Device Lot Number: 0000005657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23360 DA