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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383512
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  malfunction  
Event Description
It was reported that 1 bd nexiva¿ closed iv catheter system had a damaged device issue.The following information was provided by the initial reporter translated from chinese to english : the head nurse of ct room reported that there were burrs when she opened the package.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph of a 22 ga x 1.00 in nexiva single port from lot number 1071130.A visual inspection of the photo discovered a black spot on the needle.The photo itself is difficult to determine if it is foreign matter or damage to the needle.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.The photograph provided for this incident did not present sufficient evidence to identify a definite root cause.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
 
Event Description
It was reported that 1 bd nexiva¿ closed iv catheter system had a damaged device issue.The following information was provided by the initial reporter translated from chinese to english : the head nurse of ct room reported that there were burrs when she opened the package.
 
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Brand Name
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15085223
MDR Text Key304802435
Report Number1710034-2022-00380
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903835126
UDI-Public00382903835126
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 09/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2024
Device Catalogue Number383512
Device Lot Number1071130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2021
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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