• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD¿ WHITACRE SPINAL TRAY ANESTHESIA CONDUCTION KIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION, INC BD¿ WHITACRE SPINAL TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405671
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. The customer's address is unknown. (b)(6) has been used as a default. Device manufacture date: unknown. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. A device history review could not be completed as no batch number was provided. Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure. Root cause description: no root cause can be determined as no samples were received. Rationale: no batch#/sample available no further investigation required.
 
Event Description
It was reported that the needle in the bd¿ whitacre spinal tray was "1 1/2"", but was incorrectly labeled as a "1"" needle. The following information was provided by the initial reporter: "the 3ml syringe bd luer-lok w/25g x 1" needle should be a 1 1/2" needle. If you look at the ref # 400866 that we've been using for the past year, it has a 1 1/2" needle. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD¿ WHITACRE SPINAL TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key9658870
MDR Text Key195544779
Report Number1625685-2020-00012
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904056711
UDI-Public00382904056711
Combination Product (y/n)N
PMA/PMN Number
DISCRETION
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number405671
Device Catalogue Number405671
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/03/2020 Patient Sequence Number: 1
-
-