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

Model Number	NEPI-3717-20
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suspect device was unable to provide adequate anesthesia.No patient injury was reported.
Additional 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 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.No information has been provided to date) this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: PORTEX SPINAL (SDD) 25G W/DRUGS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15316078
• Report Number: 3012307300-2022-16605
• Device Sequence Number: 14832326
• Product Code: CAZ
• UDI-Device Identifier: 15019517115314
• UDI-Public: 15019517115314
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown