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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER
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BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383692
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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¿ diffusics¿ closed iv catheter system experienced leakage.The following information was provided by the initial reporter: apparently, the device leaks where the pen is in the photo.
 
Event Description
It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system experienced leakage.The following information was provided by the initial reporter: apparently, the device leaks where the pen is in the photo.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-08-25.Investigation summary: bd received one sample submitted for evaluation.The reported issue was confirmed upon flow testing of the sample.Bd determined the root cause to be insufficient adhesive at the connection site of the catheter tubing and luer adapter.Insufficient adhesive can occur from a dispense system malfunction or incorrect adhesive location during our manufacturing processes.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.There are currently controls in place during our manufacturing process to help prevent this failure.H3 other text : see h10.
 
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Brand Name
BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM
Type of Device
INTERVASCULAR CATHETER
MDR Report Key12389458
MDR Text Key271329944
Report Number9610847-2021-00408
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K173354
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 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2024
Device Catalogue Number383692
Device Lot Number1020215
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Date Manufacturer Received09/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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