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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE; ANESTHESIA CONDUCTION KIT
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BECTON DICKINSON TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405671
Device Problem Lack of Effect (4065)
Patient Problem Pain (1994)
Event Date 01/31/2024
Event Type  malfunction  
Event Description
Material#: 405671 lot#: 0001536091, 0001537529 it was reported by the customer reported i am writing regarding spinal trays having medication not working during procedures.Patient is feeling pain.Verbatim: rcc received a complaint via email.Email(s) attached.I am writing regarding spinal trays having medication not working during procedures.Patient is feeling pain.Item# 405671 ((b)(4)) lot# 0001536091 lot# 0001537529.
 
Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
 
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Brand Name
TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18751785
MDR Text Key336785548
Report Number1625685-2024-00020
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number405671
Device Lot Number0001537529
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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