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

Catalog Number XX-RF06

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

Patient Problem Inflammation (1932)

Event Date 10/04/2016

Event Type  Injury  

Manufacturer Narrative

Not required for this product code.The actual device was discarded by the involved facility and the lot number was not provided.Therefore, the investigation was limited to evaluation of the user facility information and quality documents for this product group.Sterilization, endotoxin and eto residual testing documentation was reviewed from the past two and a half years and confirmed no relevant findings.Review of the specification change record going back to the past two and half years confirmed no changes in the materials, the shape or the size of the balloons to date.The production lot number was not provided by the user facility, which prevented a meaningful review of production and complaint records.There is no evidence that this event was related to a device defect or malfunction.With no evaluation of the actual device, the cause of the reported event cannot be definitively determined.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: "if there is itching or redness of the skin while compression, stop using and treat appropriately." (b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Device discarded.

Event Description

The user facility reported that the patient developed inflammation during the use of the tr band device.Follow up communication with the user facility confirmed the following information: (1) when the patient came back to the ward, some blisters were found to have developed on the wrist where the tr band device was applied; and (2) the procedure was completed successfully.

• Brand Name: TR BAND
• Type of Device: VASCULAR CLAMP
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6057722
• MDR Text Key: 58401995
• Report Number: 9681834-2016-00238
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XX-RF06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 10/26/2016
• 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
• Patient Outcome(s): Other