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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEOFLON 26GA 0.6MM OD 19MM L; INTRAVASCULAR CATHETER
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NEOFLON 26GA 0.6MM OD 19MM L; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 391349
Device Problems Leak/Splash (1354); Material Separation (1562); Device Contamination with Chemical or Other Material (2944)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 05/31/2021
Event Type  Injury  
Manufacturer Narrative
Initial reporter phone#: (b)(6).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 neoflon 26ga 0.6mm od 19mm l separated during insertion on 100 occasions.The following information was provided by the initial reporter: it hangs at the time of the puncture.The plastic part separates from the mandrel during insertion.The mandrain deviates.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-06-30.H6: investigation summary: three used samples were received by our quality team for evaluation.The samples were subjected to visual inspection and peelback was observed.A device history record review found no non-conformances associated with this issue during production of this batch.The probable root cause for peelback could be due to the tubing material.A trend for the peelback issue has been identified for this product line.The appropriate personnel have been notified of this complaint.We have funded a project to examine how to further increase the robustness of the bd neoflon device and prevent future occurrences of this type.As part of the action plan, changes to the catheter material and method of shaping the catheter tip are in the process of being implemented.Customer complaint trends will also continue to be evaluated on a monthly basis.Capa 81917 has been initiated.
 
Event Description
It was reported that neoflon 26ga 0.6mm od 19mm l separated during insertion on 100 occasions.The following information was provided by the initial reporter: it hangs at the time of the puncture.The plastic part separates from the mandrel during insertion.The mandrain deviates.
 
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Brand Name
NEOFLON 26GA 0.6MM OD 19MM L
Type of Device
INTRAVASCULAR CATHETER
MDR Report Key12132260
MDR Text Key262886908
Report Number8041187-2021-00567
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
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 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2023
Device Catalogue Number391349
Device Lot Number8052262
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2021
Date Manufacturer Received07/14/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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