MAUDE Adverse Event Report: PRESSURE MONITORING KIT

Model Number PX260

Device Problem Contamination (1120)

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

Event Date 08/09/2021

Event Type  malfunction  

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.

Event Description

As reported, before use in patient, during the set up of this disposable pressure transducer, some foreign material was found inside the tubing.There was no allegation of patient injury.The product is expected to be returned for analysis; however, it has not yet been received.Patient demographics unable to be obtained.

Manufacturer Narrative

One single dpt kit was received by our product evaluation laboratory for a full examination.The report of contamination issue inside the pressure tubing was confirmed.One cluster of dark brown particulates was observed inside pressure tubing.The particulate was approximately 0.2" in length and 9" distal from the dpt.The particulates appeared attached to tubing wall and stayed at the same location on pressure tubing after five minutes of continuous flushing.Pressure tubing was cut, and the particulates were sent to chemistry for further analysis.Per chemistry study, the sample spectrum is consistent with that of pvc.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: PRESSURE MONITORING KIT
• MDR Report Key: 12405824
• MDR Text Key: 269303411
• Report Number: 2015691-2021-04945
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K183413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

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 Operator: Health Professional
• Device Expiration Date: 01/08/2023
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 63567928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2021
• 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