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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SPLITTABLE NEEDLE INTRODUCER 28GA (1.2F) X 20MM
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ARGON MEDICAL DEVICES SPLITTABLE NEEDLE INTRODUCER 28GA (1.2F) X 20MM Back to Search Results
Model Number 384061
Device Problem Failure to Advance (2524)
Patient Problem Insufficient Information (4580)
Event Date 07/13/2022
Event Type  malfunction  
Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
 
Event Description
An attempt was made to insert a picc.Upon entering the vein, there was blood that came back from the introducer (so it was in the vessel).The practitioner then attempted to thread the picc line through and the catheter would not pass.The practitioner had to remove the introducer.She attempted to thread it through the introducer when outside of the patient, but the catheter wouldn't pass.
 
Event Description
An attempt was made to insert a picc.Upon entering the vein, there was blood that came back from the introducer (so it was in the vessel).The practitioner then attempted to thread the picc line through and the catheter would not pass.The practitioner had to remove the introducer.She attempted to thread it through the introducer when outside of the patient, but the catheter wouldn't pass.
 
Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.One needle was returned for review.Visual inspection found the needle to have dried bodily fluids within the needle cannula.Due to the presence of the dried bodily fluids, the catheter would not advance through the needle smoothly.Therefore, this complaint was confirmed for occlusion.The most probable cause for the reported issue was most likely related to the presence of the bodily fluids that would not allow the catheter to pass through smoothly.There have been no other complaints regarding this issue with this lot number.Since the reported issue was most likely related to the user environment and not a manufacturing error, no corrective action will be taken at this time.Argon will continue to monitor for issues of this nature in the future.
 
Event Description
An attempt was made to insert a picc.Upon entering the vein, there was blood that came back from the introducer (so it was in the vessel).The practitioner then attempted to thread the picc line through and the catheter would not pass.The practitioner had to remove the introducer.She attempted to thread it through the introducer when outside of the patient, but the catheter wouldn't pass.
 
Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
 
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Brand Name
SPLITTABLE NEEDLE INTRODUCER 28GA (1.2F) X 20MM
Type of Device
SPLITTABLE NEEDLE INTRODUCER
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key15138178
MDR Text Key297186339
Report Number0001625425-2022-01050
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00886333209590
UDI-Public00886333209590
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K920755
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 09/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number384061
Device Catalogue Number384061
Device Lot Number11401781
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/21/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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