MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SPINAL SINGLE SHOT TRAYS; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number	NEPI-49661-25
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 product was within specifications.Review of the sterilization certificate for the tray lot revealed that the product was processed according to validated specification requirements and parameters.Smiths medical periodically monitors supplied drug components stability post ethylene oxide sterilization throughout their expiry.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.The anesthetics are supplied items and the complaint notification was forwarded to the supplier.Based on the available evidences and investigation results the reported by the customer complaint could not be confirmed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
Event or Problem Description
It was reported that customers have raised concern about drug's potency in spinal kits even though the drug gets good distribution.Observation is that drug only gives about 50% of the usual potency.No patient injury was reported.

• Brand Name: PORTEX SPINAL SINGLE SHOT TRAYS
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16632754
• Report Number: 3012307300-2023-03154
• Device Sequence Number: 20688720
• Product Code: BSP
• UDI-Device Identifier: 15019517115499
• UDI-Public: 15019517115499
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

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: 06/01/2021
• Device Model Number: NEPI-49661-25
• Device Catalogue Number: NEPI-49661-25
• Device Lot Number: 3807113
• 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: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown