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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER SINGLE-STEP DRAINAGE CATHETER SET WITH NON-LOCKING PIGTAIL
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ARGON MEDICAL DEVICES SKATER SINGLE-STEP DRAINAGE CATHETER SET WITH NON-LOCKING PIGTAIL Back to Search Results
Catalog Number 756006025E
Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
A review of the returned sample found the metal stiffener was found stuck in the catheter and the catheter was curled.Biological material was found inside the metal stiffener when removed.The event description explains that the issue occurred during preparation, so a possible cause could be that the dried biological material found on the metal stiffener caused the resistance experienced by the user.Once the component was cleaned, the catheter was able to advance in the device without any resistance.
 
Event Description
The cannula seemed to be stuck in the drain.When the doctor decided to pull back the cannula the catheter curled inside the patient.
 
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Brand Name
SKATER SINGLE-STEP DRAINAGE CATHETER SET WITH NON-LOCKING PIGTAIL
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key10352184
MDR Text Key202685927
Report Number1625425-2020-00448
Device Sequence Number1
Product Code GBQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial
Report Date 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number756006025E
Device Lot Number11300772
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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