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

Catalog Number 688550/D

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/30/2024

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.

Event Description

The account alleges that an rn noted in the nicu dept a patient with a bloodstain on the bed.Probably from the red sampling point (septum) of the arterial line.

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: DTX SAFEDRAW KITS.
• Type of Device: COMPUTER, BLOOD-PRESSURE
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE; 198 yishun avenue 7; yishun, 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE; 198 yishun avenue 7; yishun, 76892 6; SN 768926
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012088662
• MDR Report Key: 19088882
• MDR Text Key: 339930656
• Report Number: 8020616-2024-00014
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 00884450775028
• UDI-Public: 884450775028
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 688550/D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/07/2024
• 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
• Patient Outcome(s): Life Threatening