MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW¿; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Catalog Number 689079/JPB

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/17/2023

Event Type  malfunction  

Event Description

The account alleges that during a hemodynamic pressure monitoring procedure, the clinical staff noted that the pressure monitoring set was leaking fluid from the three-way stopcock.The device was replaced for the patient.No additional patient consequences to report.

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: SAFEDRAW¿
• 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
• 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: 16233467
• MDR Text Key: 309136213
• Report Number: 8020616-2023-00001
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K935782
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 689079/JPB
• Device Lot Number: C2524408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2023
• 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