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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 383536
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd nexiva¿ closed iv catheter system experienced no label or missing label information.The following information was provided by the initial reporter: today the 20g nexiva was identified with product code 383536 (lot 0275295) where the labelling is missing from part of the box.
 
Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs which displayed missing label content.The reported issue was confirmed.Our engineer has determined that the most likely root cause for this event is related to the splicing of one roll of packaging backing to the next.Current controls are in place to monitor and reject packaging units that lack the required packaging information; manual processes within the rejection process are subject to human error.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 experienced no label or missing label information.The following information was provided by the initial reporter: today the 20g nexiva was identified with product code 383536 (lot 0275295) where the labelling is missing from part of the box.
 
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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
MDR Report Key11935833
MDR Text Key261838607
Report Number1710034-2021-00469
Device Sequence Number1
Product Code FOZ
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 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2023
Device Catalogue Number383536
Device Lot Number0275295
Was Device Available for Evaluation? No
Date Manufacturer Received06/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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