MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE DTX SAFEDRAW KITS.SCK-PL418..STERILE.; COMPUTER, BLOOD-PRESSURE

Catalog Number 689744/JPA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

When the device was connected to a needle leakage occurred from the connection point.The connection point was tightened further, but the leakage did not improve, so the customer took out another unit and connected it.No patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

The suspect device was returned for evaluation.Leak testing was performed on the returned unit and the failure could not be replicated.The complaint could not be confirmed and a root cause could not be determined.A review of the device history record was performed and no exception documents were identified.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: DTX SAFEDRAW KITS.SCK-PL418..STERILE.
• 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 bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18321046
• MDR Text Key: 330948189
• Report Number: 8020616-2023-00023
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 00884450540305
• UDI-Public: 884450540305
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

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: 689744/JPA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 12/20/2023
• 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