MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	PXMK11076
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
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 investigation is completed.The device history record review was completed and no related non-conformances were found.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 priming at the me center and before use in a patient the connections of the pressure monitoring kit got disconnected between the dpt rotate part and three way zero stopcock.Tightening the connection did not fix the issue.There was no allegation of patient injury.The device will be available for evaluation.
Additional Manufacturer Narrative
One pressure monitoring kit was returned for evaluation.Customer report of connection between dpt and three-way zero stopcock got disconnected was confirmed.As received, rotating nut of the dpt housing male luer was separated.Rotating nut was noticed cracked in the dpt attachment side.In the attempt of tighten the pressure line rotating nut separated.No other damage was observed from the kit.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.It was determined that the sub-assy where the issue was identified is manufactured by fong supplier and is not related to bd's manufacturing process.This supplier was notified regarding this complaint.Nevertheless, there are internal controls to avoid potential causes related to the dpt housing - male luer - detached lock nut malfunction as follows: manufacturing continuous monitoring sampling, quality assurance sampling inspection, and 100% visual inspection by manufacturing.

• Brand Name: PRESSURE MONITORING KIT
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• 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 ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22020787
• Report Number: 2015691-2025-03818
• Device Sequence Number: 8805057
• Product Code: DXO
• UDI-Device Identifier: 07460691958760
• UDI-Public: 07460691958760
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K925638
• 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): 07/18/2025

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: PXMK11076
• Device Lot Number: ZT0188MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2024
• 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