MAUDE Adverse Event Report: PORTEX; PAIN MANAGEMENT EPIDURAL TRAY

Model Number A3998-17

Device Problem Disconnection (1171)

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

Event Date 04/02/2021

Event Type  malfunction  

Event Description

Primary rn noted that the epidural catheter was disconnected/broken off below the yellow portion of the epidural tubing.The patient was in the bathroom at this time.Charge rn (this rn) wrapped the end of the catheter with sterile gauze and notified aps, who came and saw the patient immediately.Because subcutaneous heparin had been recently given, aps was unable to pull the epidural.Md placed a new ending on the catheter with plans to pull the epidural catheter six hours after the recent heparin dose.

Manufacturer Narrative

Other, other text: no product sample has been returned.The customer provided two photos for evaluation (see attached in cc-01061220).Evaluation of the photos revealed connector/filter assembly without any visible anomalies.The condition of the catheter could not be assessed as it was not present on the photo.The reported problem could not be verified and/or confirmed with confidence; therefore, no further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and take further actions accordingly.

Event Description

No product was returned.Summary from sme in h 10.

• Brand Name: PORTEX
• Type of Device: PAIN MANAGEMENT EPIDURAL TRAY
• MDR Report Key: 11794913
• MDR Text Key: 249678820
• Report Number: 3012307300-2021-04072
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A3998-17
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR