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

Catalog Number 689128/JPA

Device Problem Fracture (1260)

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

Event Date 04/08/2021

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 close to the planecta.The pm set was replaced.No patient injury to report.

• Brand Name: DTX SAFEDRAW PM KITS
• Type of Device: PRESSURE MONITORING SET
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, sgp 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, sgp 76892 6; SN 768926
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 11791006
• MDR Text Key: 249541032
• Report Number: 8020616-2021-00026
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884450356098
• UDI-Public: 884450356098
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K935782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2021

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: 11/29/2023
• Device Catalogue Number: 689128/JPA
• Device Lot Number: C1989793
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1