MAUDE Adverse Event Report: PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VO3906TSPL03

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

One single flothru dpt-vamp flex kit with iv set and pressure tubing was returned for evaluation.Solution was visible in the kit.Pressure tubing remained coiled with paper band.The reported event of contamination was confirmed.One unknown red material was observed in fluid path of the kit at connection between the male luer of planecta and the female connector of pressure line.The material was approximately 0.5 mm x under 0.5mm in size.The material stayed at the same location after 5 minutes of continuous flushing.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.

Event Description

It was reported that an unknown red string-like material was found inside the luer lock connector connected to the planecta in an opened package during priming.Patient demographic information is unknown.The device was exchanged.There were no patient complications reported.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.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.

Manufacturer Narrative

The foreign material was sent to chemistry for analysis.Per chemistry study the ir spectrum of the unknown red material was consistent with that of poly (butadiene : acrylonitrile).This component is provided by a third party supplier who was notified of this issue.Their investigation did not show a relationship between their manufacturing process and the red material.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: PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• MDR Report Key: 12389178
• MDR Text Key: 268963513
• Report Number: 2015691-2021-04920
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2023
• Device Model Number: VO3906TSPL03
• Device Lot Number: PJ0432MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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