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

Catalog Number 689128

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/05/2021

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 from a crack under the male adaptor.No patient injury.

• Brand Name: DTX SAFEDRAW PM KITS
• Type of Device: PRESSURE MONITORING SET, PRODUCT CODE
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 11739351
• MDR Text Key: 247770196
• Report Number: 8020616-2021-00022
• 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: 04/05/2021

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 Catalogue Number: 689128
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1