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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 22GA 1.00IN Y INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 22GA 1.00IN Y INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383532
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that nexiva 22ga 1. 00in y was expired. The following information was provided by the initial reporter: customer called to advise that she is a nurse and has used a bd nexiva device on a patient with an expired date.
 
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Brand NameNEXIVA 22GA 1.00IN Y
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key12047010
MDR Text Key260828031
Report Number1710034-2021-00524
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903835324
UDI-Public00382903835324
Combination Product (y/n)N
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 07/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2020
Device Catalogue Number383532
Device Lot Number7332592
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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