MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE SAFEDRAW¿; PM TRANSDUCER HEMODYNAMIC MONITOR,

Catalog Number 689128

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/09/2021

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 blood from the 3-way marvelous stopcock.The pm set was exchanged, and the procedure was successfully completed.No additional patient consequences to report.Device is returning for investigation.

Manufacturer Narrative

The suspect device has been returned for evaluation.The device was examined visually and microscopically.No cosmetic defect was identified.Functional testing was performed, and device performed as intended.The complaint could not be confirmed.No leaks could be identified during functional testing.The root cause is undetermined.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: SAFEDRAW¿
• Type of Device: PM TRANSDUCER HEMODYNAMIC MONITOR,
• 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: 13052940
• MDR Text Key: 284528179
• Report Number: 8020616-2021-00100
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 04589731125085
• UDI-Public: 4589731125085
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 689128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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