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

Model Number	A2832-25
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2022-17716
• Device Sequence Number: 6078066
• Product Code: CAZ
• UDI-Device Identifier: 00351688061761
• UDI-Public: 00351688061761
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2022

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: A2832-25
• Device Catalogue Number: A2832-25
• Device Lot Number: 3989503
• Was Device Available for Evaluation?: No
• 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: 09/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown