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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
Model Number 405671
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4). Medical device expiration date: unknown. Device manufacture date: unknown. 510k number: enforcement discretion.
 
Event Description
It was reported that tray spn whit25g3. 5 l/b-d/e plast drape had an ineffective anesthesia syringe. The following information was provided by the initial reporter: "it was reported that the bupivicaine in the trays are ineffective. Customer called to report that the bupivicaine is ineffective in the spinal trays. She stated that it has happened several times. They had to re-administer the patient and pull from their stock. Samples from the same lot available, customer was unable to give lot at the time of the call. ".
 
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Brand NameTRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10475401
MDR Text Key207176276
Report Number2243072-2020-01332
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
SEE H.10.
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? No
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 Received12/23/2020
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: 09/01/2020 Patient Sequence Number: 1
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