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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 04/12/2021
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 had no label.This occurred on 4 occasions.The following information was provided by the initial reporter: this is a report about missing labels on packages.According to the customer¿s report, no label was affixed to 4 packages in a carton.
 
Manufacturer Narrative
Investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received four photographs which displayed the packages that were absent labeling information.The reported issue was confirmed.Misprints and missing prints can occur during the printing step of the packaging process.Automated inspections systems are in place to monitor this issue and remove the non-conforming device from the production line.Operators review the scrapped devices for any incorrect rejections and is subject to human error.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.
 
Event Description
It was reported that nexiva 22ga 1.00in y had no label.This occurred on 4 occasions.The following information was provided by the initial reporter: this is a report about missing labels on packages.According to the customer¿s report, no label was affixed to 4 packages in a carton.
 
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Brand Name
NEXIVA 22GA 1.00IN Y
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key11803469
MDR Text Key252706626
Report Number1710034-2021-00390
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 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2023
Device Catalogue Number383532
Device Lot Number0147311
Was Device Available for Evaluation? No
Date Manufacturer Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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