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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD CATHETER ROUND CE CATHETER INDUCER

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BECTON DICKINSON BD CATHETER ROUND CE CATHETER INDUCER Back to Search Results
Catalog Number 401497
Device Problems Material Rupture (1546); Device Or Device Fragments Location Unknown (2590)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). In this mdr, bd corporate headquarters in (b)(6) has been listed. Teleflex is an oem manufacturing site. 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 the bd catheter round ce ruptured during removal and adjustment in the epidural space. "the piece of the catheter has not been found, but there is no negative consequence for the patient at this time. " medical intervention included chest ct scan and mri of thoracic and whole spine. " no further information given at this time.
 
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Brand NameBD CATHETER ROUND CE
Type of DeviceCATHETER INDUCER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7266372
MDR Text Key100142393
Report Number2243072-2018-00023
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number401497
Device Lot NumberC17101
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 Received01/18/2018
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: 02/13/2018 Patient Sequence Number: 1
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