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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; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Model Number 383517
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2022
Event Type  malfunction  
Event Description
It was reported that the bd nexiva¿ closed iv catheter system had burrs when they opened the package.The following information was provided by the initial reporter: 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
Investigation summary our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed a 20 ga x 1.25 in nexiva single port from lot number 1109481.A visual inspection of the photo discovered some flash on the catheter tip.The reported issue was confirmed.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.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported that the bd nexiva¿ closed iv catheter system had burrs when they opened the package.The following information was provided by the initial reporter: 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
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 Key15089801
MDR Text Key304546402
Report Number1710034-2022-00387
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835172
UDI-Public30382903835172
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K102520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Model Number383517
Device Catalogue Number383517
Device Lot Number1109481
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2022
Initial Date FDA Received07/22/2022
Supplement Dates Manufacturer Received08/19/2022
Supplement Dates FDA Received09/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2021
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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