MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FLOTRAC SENSORS; CATHETER, FLOW DIRECTED

Model Number	MHD8
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
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 with this flotrac sensor, the end of the pressure tubing, the stopcock luer was detached.There was no allegation of patient injury.The device was available for evaluation.
Additional Manufacturer Narrative
Finally, the device was not received for evaluation.Nevertheless, two customer photos were provided for evaluation.Based on the image review, the photos showed a flotrac housing male luer completely broken rather than detached.Stopcock/luer broken could lead to a leakage that implies a small amount of blood/fluid loss that is unlikely to result in an injury.This generally results in the need to exchange the device, which can be done with a minor delay in treatment or monitoring.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.

• Brand Name: FLOTRAC SENSORS
• Common Device Name: CATHETER, FLOW DIRECTED
• 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: 19938356
• Report Number: 2015691-2024-05964
• Device Sequence Number: 4877457
• Product Code: DYG
• UDI-Device Identifier: 00690103194609
• UDI-Public: (01)00690103194609(17)251004(11)231005(10)65281939
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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 Expiration Date: 10/04/2025
• Device Model Number: MHD8
• Device Lot Number: 65281939
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2023
• 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