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

Model Number	PXVMP172AT3
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.
Event or Problem Description
It was reported that before use, a particulate was found in this pressure tube.This was detected before customer use.The physician is not able to tell if the material is inside the tube or embedded in the plastic.There is no patient involvement.
Additional Manufacturer Narrative
A capa was initiated for this issue and the supplier has been notified of the malfunction.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.
Additional Manufacturer Narrative
One single dpt - vamp adult kit was returned for evaluation.The reported event of contamination issue was confirmed.One unknown dark brown particulate, approximately 80 cm distal from dpt housing, was observed inside pressure tubing.The particulate, approximately 0.04" x 0.18" in size, attached to the inner wall of pressure tubing.The particulate stayed at the same location on pressure tubing after 5 minutes of continuous flushing.Pressure tubing was cut and the particulate was sent for additional tests.Additional test confirmed that the returned sample is consistent with the material like pvc.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.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER 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 ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 12632933
• Report Number: 2015691-2021-05662
• Device Sequence Number: 4380684
• Product Code: DXO
• UDI-Device Identifier: 07460691950405
• UDI-Public: (01)07460691950405(17)230407(11)210407(10)63723408;(01)57460691950400(17)230407(11)210407(10)63723408
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2021

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 Model Number: PXVMP172AT3
• Device Catalogue Number: PXVMP172AT3
• Device Lot Number: 63723408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• 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: 09/23/2021
• Supplement Date Received by Manufacturer: 10/25/2021; 12/14/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/16/2021; 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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