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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cyanosis (1798)

Event Date 06/07/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: requested, not available due to hospital policy.Age & date of birth: requested, not available due to hospital policy.Patient sex: requested, not available due to hospital policy.Weight: requested, not available due to hospital policy.Ethnicity: requested, not available due to hospital policy.Race: requested, not available due to hospital policy.Lot number: requested, unknown.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.Device manufacture date: unknown due to unknown lot number.The actual device was not available; therefore, the actual device will not be 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 registered nurse (rn) had an unknown issue with the tr band.There was no patient injury/medical or surgical intervention required.The event occurred post-treatment.Additional information was received on (b)(6) 2022: it was confirmed by the tech that the patient had a blue hand and that it might have been a high stick and that there might have been to much pressure on the artery.The patient was in fine condition.The outcome of the procedure was successful.No other equipment was used with the product involved.Additional information was received on (b)(6) 2022: 10ml of air was injected into the tr band when it was applied.How hemostasis was achieved and how long the patient had a blue hand was unknown.Additional information was received on (b)(6) 2022: the blue hand subsided and the patient did not have any further issues.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The sample was not available for evaluation.The complaint can be confirmed since the patient had a blue hand.The exact root cause cannot be determined.The likely root cause is the user applied too much pressure to the artery.The device history record (dhr) could not be reviewed since the lot number was not provided.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14799814
• MDR Text Key: 302096969
• Report Number: 1118880-2022-00052
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1