MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SPINAL TRAY (SDD) W/DRUGS; PAIN MANAGEMENT|PORTEX SPINAL CUSTOM SINGLE SHOT

Lot Number 3988193

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

Assay testing, performed by the supplier prior to release of bupivacaine was within specification.Review of the sterilization certificate for the tray revealed that the product was processed according to validated specification requirements and parameters.Supplied drug components stability post ethylene oxide sterilization are periodically monitored throughout their expiry.Our records show that the supplied drug components continue to meet potency specifications.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.Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.Catalog and udi unknown, 510k unknown.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 bupivacaine in the trays are not working.No patient injury was reported.

• Brand Name: SPINAL TRAY (SDD) W/DRUGS
• Type of Device: PAIN MANAGEMENT|PORTEX SPINAL CUSTOM SINGLE SHOT
• 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: 15328775
• MDR Text Key: 305418113
• Report Number: 3012307300-2022-17065
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• 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 Lot Number: 3988193
• 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: 05/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1