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

Model Number N/A

Device Problems Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

Lot number: requested, not provided.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 has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, investigation conclusions code 11 has been referenced.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 tr band was releasing air post cardiac prior to adding the syringe.Additional information was received on 25may2021: the patient received a angiomax, it was supposed to be a two hour wait to release air.When the nurse went in the room to release air at 1320, she noted that the air bubble was "soft" as if some air had already been released.She slowly released air per protocol.Nurse charted: (r) radial band placed at 1120.Patient back to floor at 1130.Patient was with stable vitals and full sensation and warmth to right hand.Band remained in place until 1320 and air released over 15min intervals with no bleeding; gauze and tegaderm placed at site.A regular sized tr band was used.It was reported that it seemed like there might be a small air leak but nothing too obvious for product defect.The nurse noticed that syringe was sticking to the air valve but doesn't seem to be the issue in this case.

Manufacturer Narrative

This report is being submitted as follow up no.1 to report that this reported event has been deemed not reportable based off the investigation of the actual device; inspection of the returned sample upon receipt found that the device had no airflow issues because the device passed leak testing.There were no air bubbles noted at the inflation balloon or the large and small balloons.The device involved in this complaint has been verified to be of normal product; therefore, is not a reportable event.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11992778
• MDR Text Key: 257249138
• Report Number: 1118880-2021-00139
• 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: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• 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: 06/09/2021
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GAUZE AND TEGADERM PLACED AT SITE