MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR EDWARDS OXIMETRY CENTRAL VENOUS CATHETER; CATHETER INTRODUCER

Model Number	X3820SJD
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the results become available.The dhr was not completed as no lot number was provided.Complaint histories for all reported events are reviewed against trending control limits, on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Event or Problem Description
It was reported while using the x3820sjd catheter that propofol injection leaked out of the optical module connector during use.No patient injury was reported.
Additional Manufacturer Narrative
The x3820sjd was returned for evaluation.Customer report of leakage issue was confirmed.Leakage was detected between distal lumen and optical fiber lumen inside backform.No leakage or occlusion was observed in proximal and medial lumens.No other visible damage/inconsistency was observed from the returned catheter, especially at catheter tip.A cut down of the backform was performed for further evaluation, and a gap was observed inside the backform between distal lumen and optical fiber lumen that could lead to internal leakage.The backform was from #4 mold cavity.The lot number of the affected unit of this complaint is unknown; therefore, the device history record could not be performed.As part of the manufacturing process, 100% of the units go through a dry leak test performed as procedure.This dry leak test is performed after the backforming process and in the sub assembly manufacturing process as well.A capa was generated on 11/18/2024 to investigate and perform actions regarding the interlumen leakage between distal lumen and optical lumen of presep products as the failure mode is associated to a manufacturing/design defect.

• Brand Name: EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 20839836
• Report Number: 2015691-2024-09102
• Device Sequence Number: 18138635
• Product Code: DQE
• UDI-Device Identifier: 00690103197433
• UDI-Public: 00690103197433
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: X3820SJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown