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

Catalog Number 688077/B

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The account alleges that during an arterial hemodynamic monitoring on an infant patient, the medical staff noted that the pressure monitor tubing had disconnected while prepping the patient for device use.No patient injury to report.

Manufacturer Narrative

Only part of the suspect device was returned for investigation.The device was inspected visually and functional testing was performed.The complaint could not be confirmed.The possible root cause could be contributed to the medical staff not fully tightening all connections during preparations of the device per ifu.Review of the manufacturing process showed no changes.No visual non-conformities could be identified.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. PM SET
• Type of Device: COMPUTER, BLOOD-PRESSURE
• 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: 15473358
• MDR Text Key: 302070391
• Report Number: 8020616-2022-00074
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 00884450372968
• UDI-Public: 884450372968
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K885235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 688077/B
• Device Lot Number: C2157594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2021
• 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