MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. MERITRANS DTXPLUS; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number 682000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that there are cracks, and leakage near the connection between the sensor and the infusion set.No patient injury to report.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during use.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.

• Brand Name: MERITRANS DTXPLUS
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, sgp 76892 6; SN 768926
• MDR Report Key: 10543409
• MDR Text Key: 207229665
• Report Number: 8020616-2020-00050
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00886333620005
• UDI-Public: 00886333620005
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 682000
• Device Catalogue Number: 682000/CNA
• Device Lot Number: C1512123
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1