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

Model Number PX260

Device Problem Contamination (1120)

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

Event Date 03/21/2022

Event Type  malfunction  

Event Description

As reported, before use in patient, the device sterility of this disposable pressure transducer was compromised because it was not sealed tightly being exposed to outside environment.The device sterility was compromised.There was no allegation of patient injury.The device was available for evaluation.

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.

Manufacturer Narrative

It was further informed that the device was not received for evaluation due to covid-19 lockdown.Upon further review, patient demographics were not available to be obtained.Based on engineering investigation performed, it was concluded that without the return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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.H3 other text : not received.

Manufacturer Narrative

The device involved in this case was received for evaluation.Based on evaluation performed, the reported event of opened seal was confirmed.The package was received with partially open seal.The tyvek lid was open at bottom right corner.Adhesive was evident at the open seal area.The adhesive transfer appeared complete without any visual interruption.There was no other visible abnormality from the package.As per product evaluation results, the packaging is damaged in a way, that it is always detected prior to use and could not go undetected; therefore potential for death or serious injury is remote.In general, packaging non-conformances that results in a breach of the sterile package (i.E.Pinhole, tear or seal issue) have the potential to result in a serious infection.In this case, there is evidence that packaging was damaged in an extent that made it easily possible for edwards quality control personnel or the user of the device to detect the non-conformance.The packaging is damaged in a way, that it is always detected prior to use and could not go undetected.As such, this event is no longer considered reportable, and a corrected supplemental report is being submitted.

• 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: 14102405
• MDR Text Key: 297600484
• Report Number: 2015691-2022-05039
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2022

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 Expiration Date: 06/21/2023
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 63826284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 06/23/2022; 06/23/2022
• Supplement Dates FDA Received: 05/27/2022; 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1