MAUDE Adverse Event Report: PORTEX SPINAL SINGLE SHOT TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number NEPI-NLD-15597-20

Device Problem Infusion or Flow Problem (2964)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Event Description

It was reported that bupivacane in the tray was weak.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

According to the investigation no product sample has been provided.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 bupivacaine lot # 04-072-ev was within specification.Review of the sterilization certificate for the tray lot number 4052153 (po# (b)(4) revealed that the product was processed according to validated specification requirements and parameters.Smith medical periodically monitors supplied drug components stability post ethylene oxide sterilization 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.

• Brand Name: PORTEX SPINAL SINGLE SHOT TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11315808
• MDR Text Key: 231441146
• Report Number: 3012307300-2021-01175
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• 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 Catalogue Number: NEPI-NLD-15597-20
• Device Lot Number: 4052153
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1