MAUDE Adverse Event Report: NULL PORTEX SPINAL (SDD) 25G W/DRUGS; ANESTHESIA CONDUCTION KIT

Model Number NEPI-3717-20

Device Problem Defective Component (2292)

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

Event Date 07/03/2020

Event Type  malfunction  

Event Description

It was reported that the suspect device was unable to provide adequate anesthesia.No patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.Our records show that the supplied drugs components continue to meet potency specifications.Complaint history review does not indicate any trends for the drug lot numbers reported in this complaint.There was no sample that was returned for investigation, therefore, the customer's reported complaint could not be confirmed or duplicated.No root cause could be determined since the complaint could not be confirmed since no samples or pictures were received for evaluation.Mfr site is unknown.No information has been provided to date) this remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX SPINAL (SDD) 25G W/DRUGS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15316344
• MDR Text Key: 305256527
• Report Number: 3012307300-2022-16621
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• 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: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1