MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FLOTRAC SENSOR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	MHD8
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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
As reported, before opening the package of this flotrac sensor, the package was found broken and the sterility was affected.There was no patient involved.
Additional Manufacturer Narrative
Updated section d9, h6 (component code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).The device was received for evaluation.The report of "package was found broken and the sterility was affected" was confirmed.As received both shelf box and tray were crushed at one side.A section of the seal, approximately 12 cm, of tyvek tray was found open.Complete adhesive transfer was observed at open seal area.The product sterility had been compromised.No visible damage or abnormality was observed from returned kit.The findings were aligned to the customer picture.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.The most likely cause is related to handling of the device during shipping, unpacking or storage.Packaging at bd is thoroughly tested through design verification to prove resiliency to withstand various conditions such as environmental, distribution and aging.During the manufacturing process there are controls to avoid potential causes related to the reported malfunction.

• Brand Name: FLOTRAC SENSOR
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22382421
• Report Number: 2015691-2025-05363
• Device Sequence Number: 9355073
• Product Code: DRS
• UDI-Device Identifier: 00690103194609
• UDI-Public: (01)00690103194609(17)260508(11)240508(10)65785932
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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 Expiration Date: 05/08/2026
• Device Model Number: MHD8
• Device Lot Number: 65785932
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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