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

Catalog Number 689444/JPB

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/23/2022

Event Type  malfunction  

Event Description

The account alleges that during a hemodynamic pressure monitoring procedure, the clinical staff noted a connection that was loose and disconnected between the planecta al-b2 and a 48'' (120 cm) tube near the patient.The connection was re-tightened.No additional patient consequences to report.

Manufacturer Narrative

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

Manufacturer Narrative

The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to component failure related to overtightening.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 ave 7; singapore, 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15894717
• MDR Text Key: 307880889
• Report Number: 8020616-2022-00115
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 04589731125719
• UDI-Public: 4589731125719
• 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: 11/24/2022

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 Expiration Date: 02/17/2023
• Device Catalogue Number: 689444/JPB
• Device Lot Number: C2032493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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