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	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the oximetry catheter there was a small amount of blood leakage from around the optical module connector, followed by medication leakage.The catheter was used for an adult patient.There was no allegation of patient injury.
Additional Manufacturer Narrative
The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.A device history record review was unable to be completed as the lot number is unknown.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.
Additional Manufacturer Narrative
One oximetry catheter was returned for evaluation.The customer report of leakage was confirmed.Blood was visible at optical module connector as received.Leakage was detected between distal lumen and optical fiber lumen inside backform.No leakage or occlusion was observed in proximal and medial lumens.A cut down of the backform was performed for further evaluation, and a gap was observed inside the backform that could lead internal leakage.Extension tube was also found knotted at 6.5, 10, 13, 16, and 20 cm from optical module.No other visible damage/inconsistency was observed from the returned catheter.The lot number was not provided thus a device history record was not reviewed.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.As part of the manufacturing process 100% of the units go through a dry leak test.

• 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): BD APM; 17200 laguna canyon rd; irvine CA 92603
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23293882
• Report Number: 2015691-2025-08339
• Device Sequence Number: 4824306
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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