MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX260

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

Patient demographics unable to be obtained.The product is expected to be returned for analysis; however, it has not been received yet.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 Description

As reported, before use in patient with this disposable pressure transducer, contamination was found in the white cap of the patient side.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Added: d4 (expiration date) , d9 (device availability), h4 (device manufacturer date).Updated: h6 (component code, type of investigation, investigation findings, investigation conclusions).The device was sent to our product evaluation laboratory for a full evaluation.As received, customer report of "contamination was found in the white cap of the patient side" was confirmed.Unknown black material was observed on the female vented cap.The material was not loose from female vented cap cover.No other visible damage/defect was observed from the kit during visual examination.Embedded particulates were unable to be removed from the plastic, therefore, was not sent to chemistry.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met, and inspections passed successfully.It was determined that this issue is potentially related to the supplier process; therefore, the supplier has been notified in order to perform an investigation to avoid the recurrence of this issue.Consequently, no further action is required at this time.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: 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 ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18758690
• MDR Text Key: 336003572
• Report Number: 2015691-2024-01217
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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
• Device Operator: Health Professional
• Device Model Number: PX260
• Device Lot Number: 64793416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1