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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ CATHETER

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BECTON DICKINSON UNSPECIFIED BD¿ CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problems Leak/Splash (1354); Material Protrusion/Extrusion (2979)
Patient Problem Blood Loss (2597)
Event Date 09/17/2019
Event Type  malfunction  
Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
Material no. : unknown. Batch no. : unknown. It was reported that during use of the unspecified bd¿ catheter the iv catheter broke during insertion. The following information was provided by the initial reporter: when placing an iv in a (b)(6) year old child. I accessed the vein, obtained blood return, removed needle and was further advancing catheter into pt when i noticed blood on his hand, iv catheter noted to be broken. I had to be removed and child needed to be stuck again. It was a very unfortunate event especially since this was the 4th stick on this child.
 
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Brand NameUNSPECIFIED BD¿ CATHETER
Type of DeviceCATHETER
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
8015652341
MDR Report Key9151750
MDR Text Key172710246
Report Number2243072-2019-02195
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received09/17/2019
Was Device Evaluated by Manufacturer? Yes
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: 10/03/2019 Patient Sequence Number: 1
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