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

Model Number	682028
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.Visual examination and functional testing was conducted on the returned device.The complaint is confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Corrective actions are in process.

• Brand Name: DTX PLUS DISPOSABLE PRESSURE TRANSDUCER
• Common Device Name: NONINVASIVE BLOOD PRESSURE SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 9759474
• Report Number: 8020616-2020-00011
• Device Sequence Number: 2649982
• Product Code: DXN
• UDI-Device Identifier: 00886333620289
• UDI-Public: 00886333620289
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K935782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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
• Operator of Device: No Information
• 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
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1