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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN BD CATHETER

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BECTON DICKINSON UNKNOWN BD CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problems Crack (1135); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2019
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. Unknown manufacturer: 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.
 
Event Description
It was reported that the unknown bd catheter couldn't be punctured into by the nurse, leading to the discovery of a crack on the front of the device. The customer reported, ¿nurse feedback catheter couldn't be punctured into, after pulling out, a crack was found in the front end. Md registration certificate (b)(6)¿.
 
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Brand NameUNKNOWN 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 Key8383503
MDR Text Key139209009
Report Number2243072-2019-00355
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2019
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 Received02/11/2019
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: 03/01/2019 Patient Sequence Number: 1
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