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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD NEXIVA¿ CLOSED IV CANNULA SYSTEM; INTRAVASCULAR CATHETER
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BECTON DICKINSON UNSPECIFIED BD NEXIVA¿ CLOSED IV CANNULA SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2022
Event Type  malfunction  
Event Description
It was reported that the needle failed to disengage while using an unspecified bd nexiva¿ closed iv cannula system.The following information was provided by the initial reporter: the needle would not disconnect from the hub.
 
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 in sections.And the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date unknown.The date received by manufacturer has been used for this field.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.
 
Manufacturer Narrative
H.6.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.
 
Event Description
It was reported that the needle failed to disengage while using an unspecified bd nexiva¿ closed iv cannula system.The following information was provided by the initial reporter: the needle would not disconnect from the hub.
 
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Brand Name
UNSPECIFIED BD NEXIVA¿ CLOSED IV CANNULA SYSTEM
Type of Device
INTRAVASCULAR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14582414
MDR Text Key293940742
Report Number2243072-2022-00755
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 Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/16/2022
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 Sequence Number1
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