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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA CLOSED IV CATHETER SYSTEM; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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BECTON, DICKINSON AND COMPANY BD NEXIVA CLOSED IV CATHETER SYSTEM; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 393521
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/30/2024
Type of Reportable Event Malfunction
Event or Problem Description
Registered nurse (rn) opened package to iv, and needle/cap were bent.Manufacturer response for catheter, intravascular, therapeutic, short-term less than 30 days, bd nexiva closed iv catheter system (per site reporter).
 
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Brand Name
BD NEXIVA CLOSED IV CATHETER SYSTEM
Common Device Name
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton dr
franklin lakes NJ 07417
MDR Report Key20662447
Report Number20662447
Device Sequence Number20892432
Product Code FOZ
UDI-Device Identifier00382903935215
UDI-Public(01)00382903935215
Combination Product (Y/N)N
Initial Reporter StateVA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type User Facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/07/2024
Report Date (Section F) 10/07/2024
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
Operator of Device Health Professional
Device Model Number393521
Device Catalogue Number393521
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location Outpatient Treatment Facility
Date Report to Manufacturer11/12/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/12/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
Patient SexPrefer Not To Disclose
Date Report Sent to FDA10/07/2024
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