MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, DR TRANSDUCER, PRESSURE, CATHETER TIP; PRESSURE MONITORING SET

Model Number PX272

Device Problem Disconnection (1171)

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

Event Date 12/18/2023

Event Type  malfunction  

Event Description

It was reported that the stopcock on the pressure monitoring set, model px272, was loose and became disconnected from the line, during use.The clinician tightened the connection.There was no report of leakage.There was no patient injury.There was no patient complications reported.

Manufacturer Narrative

The device has not arrived for evaluation.When it has been returned and evaluated a supplemental report will be submitted with the evaluation findings.The lot number is unavailable; therefore, the device history record review has not been completed.

Manufacturer Narrative

The product was returned for evaluation.The product evaluation found that the reported issue was not confirmed.All connections were tight as received.There was no visible damage or inconsistency observed from the kit.The stopcock connections were tight, during visual examination.There was no leakage observed from the kit.There were no luer connections loose or detached that were noted.Further inspection was performed for a dimensional evaluation.All male and female luers of the dpt housing, dpt stopcocks and tubing connectors dimensionally passed iso standards.There was no defect found.No escalation is required.The lot number of the product was received and the device history record review was completed.All manufacturing inspections passed with no non conformances.This supplemental mdr is being submitted due to product evaluation findings.Sections d3, g6, h2, h6: type of investigation, investigation findings, and investigation conclusions have been updated.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.

• Brand Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Type of Device: PRESSURE MONITORING SET
• Manufacturer (Section D): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr sanchez km 18.5; haina, san cristobal CA ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina san cristobal
• Manufacturer Contact: katheryn richards ; one edwards way; irvine, CA 92614
• MDR Report Key: 18470286
• MDR Text Key: 332991808
• Report Number: 2015691-2024-00161
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

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 Model Number: PX272
• Device Lot Number: 64933506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2023
• 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