MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. DTX PLUS DISPOSABLE PRESSURE TRANSDUCER NONINVASIVE BLOOD PRESSURE SYSTEM

Model Number 682028

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device has been returned for evaluation. A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that a hole was found in the tubing of the device before use on a patient. No adverse consequences were reported.

• Brand Name: DTX PLUS DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: NONINVASIVE BLOOD PRESSURE SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer Contact: david lockridge ; 1600 merit parkway; south jordan, ut ; 2084551
• MDR Report Key: 9759474
• MDR Text Key: 191671903
• Report Number: 8020616-2020-00011
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2020
• Device Model Number: 682028
• Device Catalogue Number: 682028
• Device Lot Number: 507147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial