MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR EDWARDS OXIMETRY CENTRAL VENOUS CATHETER; CATHETER, OXIMETER, FIBEROPTIC

Model Number	X3820SJD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for product evaluation.Without return of the unit, it is not possible to determine if there was damage or a defect that existed on the unit that could have contributed to the event or if any procedural factors may have contributed to the reported issue.The device history record review was completed and the product passed without nonconformances.As part of the manufacturing process, 100% of the units go through optical inspection and a dry leak test.This dry leak test is performed after the backforming process and in the sub assembly manufacturing process as well.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.
Additional Manufacturer Narrative
Additional product codes include: dre dilator, vessel, for percutaneous catheterization.Dxg computer, diagnostic, pre-programmed, single-function.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 investigation is completed.The device history record review has not yet been completed.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 a part of the monthly review.
Event or Problem Description
As reported during use in a patient this oximetry catheter had leakage from the optical module connector.The leaked solution was transparent and could be saline, but it was unable to be confirmed.No additional treatment was required due to this event.There was no allegation of patient injury.The device will be available for evaluation.

• Brand Name: EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
• Common Device Name: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 23881651
• Report Number: 2015691-2025-10523
• Device Sequence Number: 4669238
• 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): 01/28/2026

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
• Device Lot Number: 66619369
• Was Device Available for Evaluation?: No
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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