MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX PENCIL POINT SPINAL ANESTHESIA TRAYS; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number NEPI-NLD-15597C-20

Device Problems Product Quality Problem (1506); Failure to Deliver (2338)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

Udi information is unknown.Product samples were received to perform an investigation.Visual evaluation of the returned bupivacaine ampules and lidocaine ampules with unaided eye found no visible non-conformities.The drug liquid was found to be clear (colorless) with no particulates visible inside the vials.Device history record (dhr) review and incoming records found no discrepancies or anomalies relevant to the complaint.Assay testing, performed by the supplier prior to release of bupivacaine and lidocaine was within specification.Review of the sterilization certificate for the tray lot number revealed that the product was processed according to validated specification requirements and parameters.Records show that the supplied drugs components continue to meet potency specifications.Complaint history review did 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 evidence and investigation results the reported problem by the customer could not be confirmed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the medication in the tray did not work.Anesthesiologist used the drug and the patient did not receive pain control.Another type of anesthesia had to be provided for the procedures.No patient injury was reported.

• Brand Name: PORTEX PENCIL POINT SPINAL ANESTHESIA TRAYS
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• 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: 15326901
• MDR Text Key: 305088425
• Report Number: 3012307300-2022-16951
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: NEPI-NLD-15597C-20
• Device Lot Number: 3902841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1