MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; ANESTHESIA CONDUCTION KIT

Model Number NEPI-3717-20

Device Problem Product Quality Problem (1506)

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

Event Date 07/31/2020

Event Type  malfunction  

Event Description

It was reported that the medication in the tray didn't work.The customer stated that the events occurred three times within the month of (b)(6).All of those times the medication in the tray was used and did not provide adequate anesthesia for the patient.No patient injury was reported.

Manufacturer Narrative

Device history record (dhr) review found no discrepancies or anomalies relevant to the complaint.Incoming records review for bupivacaine and lidocaine including the certificates of analysis, provided by the supplier, revealed no discrepancies that may have contributed to a complaint of this nature.Assay testing, performed by the supplier, was within specification for the drug lot number(s) relevant to this complaint.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15362960
• MDR Text Key: 305790377
• Report Number: 3012307300-2022-17969
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 15019517115314
• UDI-Public: 15019517115314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: NEPI-3717-20
• Device Catalogue Number: NEPI-3717-20
• Device Lot Number: 3960851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1