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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

Expiration date - unknown due to unknown lot number.Udi - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Reporter occupation - ccl business manager.Device manufacturer date - unknown due to unknown lot number.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

Event Description

The user facility reported that the tip of the tr band syringe broke off in the valve when a nurse on the floor was removing air.This was post lhc on the floor and did not affect the procedure.Patient was fine and the air was reduced safely.There were no adverse events.The procedure outcome was successful.There was no patient injury, medical/surgical intervention required.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.One 24 cm tr regular band assembly and its inflator was returned for product evaluation.The inflator was returned with the tip broken off.Visual inspection of the check valve revealed that the tip of the inflator was stuck inside the check valve.The inflator tip could not be removed from the check valve.No further damage or anomalies were noted on the inflator or the tr band.The complaint can be confirmed for mechanical damage based on the damage noted on the return sample.It is likely that the inflator was subjected to a bending force at the joint, resulting in the breakage.The dhr review could not be performed since the lot number was not available.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 12231973
• MDR Text Key: 264265508
• Report Number: 1118880-2021-00181
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1