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 07/15/2020

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 a connection was loose, causing fluid leakage.The connection was re-tightened, but the account reports that it could not be completely fastened, and the leakage continued.No patient injury to report.

Manufacturer Narrative

The suspect device has been returned for evaluation.The device was examined visually, and functional testing was performed no leakage, loose connection or any failure observed on the product returned.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• 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: 10543384
• MDR Text Key: 207232186
• Report Number: 8020616-2020-00052
• 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: 09/11/2020

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 Model Number: 682000
• Device Catalogue Number: 688024/JPA
• Device Lot Number: C1773978
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1