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

Model Number A2832-25

Device Problem Defective Device (2588)

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

Event Date 08/21/2020

Event Type  malfunction  

Event Description

It was reported that the bupivacaine in the trays are not working.The customer identified two lots that they believe to have device issue.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.Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.Assay testing, performed by the supplier prior to release of the suspect device was within specification.Review of the sterilization certificate for the tray lot number provided by the customer revealed that the product was processed according to validated specification requirements and parameters.Complaint information review found no trends relevant to the drug lot number, reported in this complaint.The anesthetics are supplied items and the complaint notification was forwarded to the supplier.Based on available information and evidences no product quality problem could be confirmed.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX SINGLE SHOT EPIDURAL TRAYS
• 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: 15353912
• MDR Text Key: 305380503
• Report Number: 3012307300-2022-17716
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00351688061761
• UDI-Public: 00351688061761
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2022
• 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: A2832-25
• Device Catalogue Number: A2832-25
• Device Lot Number: 3989503
• Was Device Available for Evaluation?: No
• 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: 05/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1