MAUDE Adverse Event Report: PORTEX; ANESTHESIA CONDUCTION KIT

Model Number 4917M-19

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 03/03/2021

Event Type  Injury  

Event Description

It was reported that a smiths medical catheter broke off while inserted in the patient.When the anesthesiologist went to remove the catheter and reposition it, the tip was disconnected.Ct scan was performed and confirmed it remained inside of patients back.Patient currently has no neurologic symptoms and neurosurgery was consulted and recommended no current need for surgical intervention.No further medical intervention was necessary.The patient was discharged stable, and anesthesia will continue to follow up with the patient.

Manufacturer Narrative

Other, other text: additional information: h10: information was received on 12-apr-2021 indicating that no significant harm at discharge was noted, anesthesiologist was able to place an epidural catheter one space below initial insertion site.It was also noted that the patient required imaging (spine ct) to determine size and location of retained piece; no medications or surgical procedures were ordered related to the retained piece.Patient is discharged and at home and will follow up by anesthesia.

• Brand Name: PORTEX
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11611915
• MDR Text Key: 243911021
• Report Number: 3012307300-2021-02822
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00351688047574
• UDI-Public: 00351688047574
• Combination Product (y/n): N
• PMA/PMN Number: K092657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4917M-19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2021
• 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: N
• Patient Sequence Number: 1
• Patient Age: 33 YR