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

Catalog Number 689348/JPB

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/19/2023

Event Type  malfunction  

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 an av fistula angiography procedure, the radiopaque tip on the sheath detached within the patient's graft.The foreign body was successfully retrieved from the patient with no additional consequences to report.

Manufacturer Narrative

The suspect device was not 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 KIT
• 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: 16811831
• MDR Text Key: 314003681
• Report Number: 8020616-2023-00019
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 04589731125412
• UDI-Public: 4589731125412
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

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: 689348/JPB
• Device Lot Number: C2530681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 05/08/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2022
• 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