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

Catalog Number 689378/B

Device Problem Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/23/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The account alleges that during a hemodynamic pressure monitoring procedure, it was noted that blood the sampling port was squirting blood/fluid when flushing the system.A staff member got blood/fluid in their eye and was taken to the accident & emergency room for bbp testing and eye irrigation.

Manufacturer Narrative

The device was returned for engineering evaluation.The device was visually and microscopically investigated.Functional testing was performed.The complaint could not be confirmed.No leakage or cosmetic defect was observed.The root cause could not be determined.The returned product is functioning as intended per ifu.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: DTX SAFEDRAW KITS
• Type of Device: COMPUTER, BLOOD-PRESSURE KIT
• 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 bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16678967
• MDR Text Key: 312673349
• Report Number: 8020616-2023-00017
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 00884450360545
• UDI-Public: 884450360545
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 03/27/2023

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: 689378/B
• Device Lot Number: C2350368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• 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): Required Intervention; Other