MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE; ANESTHESIA TRAY

Model Number 405671

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Awareness during Anaesthesia (1707); Headache (1880)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.

Event Description

It was reported that tray spn whit25g3.5 l/b-d/e plast drape had ineffective anesthesia.The following information was provided by the initial reporter: "it was reported that patient had to receive 2 spinals as the first spinal was with the bad marcaine, resulting with patient having a spinal headache.Pr 684960 related complaint.Issue: i know of 4 times in a one week period.After that we started not using the marcaine in the kits.I don¿t know the exact week, but i am thinking the first full week in july.We had one adverse event from a patient with a spinal headache.She had to have 2 spinals as the first one was the bad marcaine.I know of 4 times in a one week period.After that we started not using the marcaine in the kits.I don¿t know the exact week, but i am thinking the first full week in july.We had one adverse event from a patient with a spinal headache.She had to have 2 spinals as the first one was the bad marcaine.".

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
• Type of Device: ANESTHESIA TRAY
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 10411615
• MDR Text Key: 204218959
• Report Number: 1625685-2020-00074
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: 00382904056711
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 07/30/2020

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: 09/30/2021
• Device Model Number: 405671
• Device Catalogue Number: 405671
• Device Lot Number: 0001350501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• 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