MAUDE Adverse Event Report: NULL PORTEX SINGLE SHOT PROCEDURAL TRAYS; ANESTHESIA CONDUCTION KIT

Model Number A3872

Device Problem Component Missing (2306)

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

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.The original shipping carton was not returned with the trays.Visual inspection of the unopened trays revealed damage to the trays outer corners of the trays.After opening the trays, it was determined that all the components for this product code were present in each tray.However, some of the components were no longer in their intended locations within the trays.There was also breakage of one of the drug ampules.Most likely this damage occurred in transit.The reported complaint was unable to be duplicated due to the original suspect device was not returned for investigation.Manufacturing site is unknown.No information has been provided to date this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that there are missing items or components with the received unit: no patient injury was reported.

• Brand Name: PORTEX SINGLE SHOT PROCEDURAL TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15365471
• MDR Text Key: 305079671
• Report Number: 3012307300-2022-18025
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 20351688077650
• UDI-Public: 20351688077650
• 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: Consumer
• Reporter Occupation: Other
• 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: 12/01/2021
• Device Model Number: A3872
• Device Catalogue Number: A3872
• Device Lot Number: 4025814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1