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

Model Number	PX260
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during receiving inspection at china ups warehouse, this disposable pressure transducer had biological materials in sterilization packaging.There was no patient involved.The device was not available for evaluation.
Additional Manufacturer Narrative
The product is not expected to be returned for analysis; however, an image was provided for investigation.An investigation will be completed to consider any potential factors that may have contributed to this complaint and 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.
Additional Manufacturer Narrative
Two photos were reviewed.Customer report of materials in the sterilization packaging was confirmed.Photo showed a tyvek pouch from reported model and lot number.In the image, a fiber-like materials were visible stuck in the sealing area.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.It could be concluded that the most probable cause for the issue is related to the manufacturing process.A personnel acknowledgment related to this complaint was provided to the manufacturing personnel.Additionally, it was verified that during the manufacturing process there are controls to avoid potential causes related to the reported malfunction.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• 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 Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 19979915
• Report Number: 2015691-2024-06095
• Device Sequence Number: 15547309
• Product Code: DXO
• UDI-Device Identifier: 07460691950191
• UDI-Public: (01)07460691950191(17)260226(11)240227(10)65598188
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: Other
• Device Expiration Date: 02/26/2026
• Device Model Number: PX260
• Device Lot Number: 65598188
• Was Device Available for Evaluation?: No
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown