MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE DTX SAFEDRAW PM KITS; PRESSURE MONITORING SET

Model Number 682000

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/30/2020

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 during the hemodynamic monitoring of a patient, the pressure monitoring [pm] set was found to be leaking fluid from a 3-way stopcock during preparation for pressure measurement.The pm set was exchanged, and the procedure was successfully completed.No patient injury to report.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually, and functional testing was performed.The complaint is confirmed.The root cause is attributed to the manufacturing process.A review of the device history record was performed, and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: DTX SAFEDRAW PM KITS
• Type of Device: PRESSURE MONITORING SET
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 11051542
• MDR Text Key: 223635559
• Report Number: 8020616-2020-00085
• 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: 12/11/2020

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 Expiration Date: 05/16/2022
• Device Model Number: 682000
• Device Catalogue Number: 688270/JPA
• Device Lot Number: C1818679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1