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.

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
• Type of Device: 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
• MDR Text Key: 191671903
• Report Number: 8020616-2020-00011
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00886333620289
• UDI-Public: 00886333620289
• Combination Product (y/n): N
• PMA/PMN Number: K935782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was 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: 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
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1