MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - SINGAPORE DTX SAFEDRAW KITS..SCK-PL053.STERILE; COMPUTER, BLOOD-PRESSURE

Catalog Number	687637
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
The tube broke in the a-line used in the emergency ward.The blood pressure tube, which had been in place for about two weeks, broke and there was bleeding from the broken area.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.The most probable cause of this occurrence is extended use of the device past the validity period.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: DTX SAFEDRAW KITS..SCK-PL053.STERILE
• 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: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21578794
• Report Number: 8020616-2025-00015
• Device Sequence Number: 9217906
• Product Code: DSK
• UDI-Device Identifier: 10884450409012
• UDI-Public: 10884450409012
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 687637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown