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U.S. Department of Health and Human Services

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

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CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405671
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Numbness (2415)
Event Date 06/25/2019
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 treatment failure occurred during use with a tray spn whit25g3. 5 l/b-d/e plast drape. The following information was provided by the initial reporter, over the last few days we had an issue with the bd spinal tray # 405671! our anesthesiologist used couple trays on same patient with no anesthesia at all or just little numbness. It happened today in labor and delivery and also happened in the weekend in the main or with different anesthesiologists. Apparently there is something wrong either manufacturing, storing, or other things, but it is affecting our work flow and patient safety. I am taking those trays out of service. We had an issue before with the tray # 405673, and now we had another issue with 405671. For me it looks like quality and safety issue. We need investigation and information about what bd will do with those complaints. We cannot afford having patient incident or safety issues or failed spinal every other day or putting our patients at risk by using unsafe trays. This is one of two complaints. This mdr captures the 2 occurrences for the date of (b)(6) 2019.
 
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Brand NameTRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer (Section G)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8799107
MDR Text Key199313776
Report Number1625685-2019-00074
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904056711
UDI-Public00382904056711
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
DISCRETION
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Catalogue Number405671
Device Lot Number0001300713
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2019
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: 07/17/2019 Patient Sequence Number: 1
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