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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEOFLON 26GA 0.6MM OD 19MM L CATHETER

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NEOFLON 26GA 0.6MM OD 19MM L CATHETER Back to Search Results
Catalog Number 391349
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)
Event Date 09/01/2021
Event Type  Injury  
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 neoflon 26ga 0. 6mm od 19mm l catheter separated from the hub. The following information was provided by the initial reporter: in the procedure of introducing the iv cannula to a (b)(6) infant, it happened that when the needle was pulled out, the teflon catheter detached from the holder and remained in the vein. With ultrasound they saw that the catheter was actually in a vessel. As they could not solve the complication on their own, the patient was urgently transferred to the university clinical center ljubljana, where he was taken over by a surgeon. We don't have more information yet. As soon as we receive them, we will let you know. Summary of adverse event at the application of iv cannula 26g on 1. 9. 2021: at the handover of the on-call service (1. 9. At 14. 25) at the pediatric ward at the girl mr (mi 163268) due to the need for transport i introduce iv cannula 26g (bd neoflon, 0. 6x19mm) in the right leg - peripheral vein superficialis. The introduction succeeds on the first attempt, there is blood reflux. When i pulled out the needle, i also have a "butterfly" in my hands, which has never happened before, because in the cannula the butterfly and the plastic catheter must be one unit - connected. I assume that the catheter has remained in the vein, so i immediately call the ward pediatrician. Dr. Does an ultrasound, where the plastic catheter is also visible. Ultrasound is also performed by dr. (the head of the internal department), who says that there will be no problems with this catheter, but that it will need to be removed in a few days. Dr. Also registers the event in the discharge form for transfer to kookit (department of pediatric surgery and intensive care in umc lj), and also calls them by phone. All present agree that this is an industrial defect.
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Brand NameNEOFLON 26GA 0.6MM OD 19MM L
Type of DeviceCATHETER
MDR Report Key12565197
MDR Text Key274563674
Report Number8041187-2021-00883
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
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 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number391349
Device Lot Number0050222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/01/2021 Patient Sequence Number: 1