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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD¿ IV SET SN404 W/O BP Y-CONN INTRAVASCULAR CATHETER

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BECTON DICKINSON BD¿ IV SET SN404 W/O BP Y-CONN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 59013833
Device Problems Loose or Intermittent Connection (1371); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/20/2018
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is (b)(4). This site is an oem manufacturing site. 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. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd¿ iv set sn404 w/o bp y-conn "separates too easily", or has a loose connection. No serious injury or medical intervention was reported.
 
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Brand NameBD¿ IV SET SN404 W/O BP Y-CONN
Type of DeviceINTRAVASCULAR CATHETER
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 Key7768806
MDR Text Key116940960
Report Number2243072-2018-01093
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/10/2021
Device Catalogue Number59013833
Device Lot Number2802211
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2018
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: 08/09/2018 Patient Sequence Number: 1
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