MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - SINGAPORE DTX SAFEDRAW KITS.; COMPUTER, BLOOD-PRESSURE

Catalog Number	682051-03
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned later, the investigation will be reopened.
Event or Problem Description
During the procedure, the tubing was found damaged and leakage fliud.No injury to report.

• Brand Name: DTX SAFEDRAW KITS.
• Common Device Name: COMPUTER, BLOOD-PRESSURE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - SINGAPORE; 198 yishun ave7; singapore 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - SINGAPORE; 198 yishun ave7; singapore 76892 6; SN 768926
• Manufacturer Contact: bryson heaton r.n. ; 1600 merit pky; south jordan, UT 84095 ; 8012665654
• MDR Report Key: 20919052
• Report Number: 8020616-2024-00051
• Device Sequence Number: 18222741
• Product Code: DSK
• UDI-Device Identifier: 10884450544157
• UDI-Public: 10884450544157
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 682051-03
• Device Lot Number: C3041212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown