MAUDE Adverse Event Report: ANESTHESIA TRAY BASIC SPINAL; ANESTHESIA CONDUCTION KIT

Catalog Number 401383

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the anesthesia tray basic spinal packaging was found damaged before use.The following information was provided by the initial reporter, translated from portuguese to english: "we identified a defective product in the box.Note: by the sent photos the package is damaged.".

Manufacturer Narrative

H.6.Investigation summary a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 9158558, and no quality issues were found during production.Our quality engineer reviewed the provided photo and determined that the pouch was torn and the box label had a small tear in the packaging.Based off the provided photos the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for investigation a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the anesthesia tray basic spinal packaging was found damaged before use.The following information was provided by the initial reporter, translated from portuguese to english: "we identified a defective product in the box.Note: by the sent photos the package is damaged.".

• Brand Name: ANESTHESIA TRAY BASIC SPINAL
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10070243
• MDR Text Key: 200666878
• Report Number: 9610048-2020-00078
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

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: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 401383
• Device Lot Number: 9158558
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 04/29/2020
• Supplement Dates FDA Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other