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

Catalog Number TRB29-LRG

Device Problem Use of Device Problem (1670)

Patient Problem Hematoma (1884)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.See mdrs 1118880-2017-00007, 1118880-2017-00008, 1118880-2017-00009, 1118880-2017-00010, and 1118880-2017-00011 that were generated for similar reports for devices that were used on multiple patients.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported multiple patients who received the tr band with the involved lot have developed a hematoma.The following information was provided by the user facility: the patient condition was good; and the case was successful.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation.The actual device was not returned to the manufacturing facility.Therefore the investigation is based on the user facility information and evaluation of retention samples.An evaluation of the retention sample from the reported lot and surrounding lots was conducted.Visual inspection revealed no defects.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: TR BAND
• Type of Device: VASCULAR CLAMP
• 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: jennifer suh ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6358229
• MDR Text Key: 68363223
• Report Number: 1118880-2017-00007
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

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: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: TRB29-LRG
• Device Lot Number: UL26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2017
• 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
• Treatment: TERUMO RADIAL PORTFOLIO