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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 03/02/2021
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 missing label information.This occurred on 4 occasions.The following information was provided by the initial reporter: this is a report about a printing issue of the package.According to the customer's report, the print was missing on 4 of 20 packages in a carton.
 
Event Description
It was reported that nexiva 22ga 1.00in y was missing label information.This occurred on 4 occasions.The following information was provided by the initial reporter: this is a report about a printing issue of the package.According to the customer's report, the print was missing on 4 of 20 packages in a carton.
 
Manufacturer Narrative
The following fields were updated due to additional information: device available for eval?: yes.Returned to manufacturer on: 3/11/2021.Investigation: bd received twenty sealed 22 gauge nexiva closed iv dual port catheter units from lot 0147311 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed that four of the packages were missing print on the top label.The engineer also reviewed the provided photos and found the same issues that were seen during the visual inspection.Based off the provided photos and visual inspection the engineer was able to verify the reported defect.It was determined that this was a manufacturing issue that occurred during the packaging process.H3 other text : see h.10.
 
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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 Key11577182
MDR Text Key242725483
Report Number1710034-2021-00243
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 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2021
Date Manufacturer Received04/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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