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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 8FR X 25CM
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ARGON MEDICAL DEVICES SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 8FR X 25CM Back to Search Results
Model Number 756508025
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 01/25/2022
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
When doing left and right intrahepatic bile duct drainage for a patient, the drainage tube is not well sealed at the exit of the pull wire outside the body, causing gas to enter the human body from it, and body fluid to leak out from the thread opening, which cannot be used.The same problem occurred.The other three directors of the same box in the same batch doctor refused to use it.However, there was no problem with the other batch numbers used later.The doctor thought that the same batch of goods would have the same problem and asked for replacement.
 
Event Description
When doing left and right intrahepatic bile duct drainage for a patient, the drainage tube is not well sealed at the exit of the pull wire outside the body, causing gas to enter the human body from it, and body fluid to leak out from the thread opening, which cannot be used.The same problem occurred.The other three directors of the same box in the same batch doctor refused to use it.However, there was no problem with the other batch numbers used later.The doctor thought that the same batch of goods would have the same problem and asked for replacement.
 
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.
 
Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.It was not necessary to check any other documentation in the course of investigating this complaint.A functional analysis was conducted, and the following findings are relevant to the complaint: two samples were received sealed and complete in their original packaging.Both samples were leak tested, and no leaks were detected.A functional review of the returned product from the customer was performed, and no leaks were detected in either sample during the leak test.The complaint is not confirmed.No defect has been detected, and no corrective action will be taken at this time.
 
Event Description
When doing left and right intrahepatic bile duct drainage for a patient, the drainage tube is not well sealed at the exit of the pull wire outside the body, causing gas to enter the human body from it, and body fluid to leak out from the thread opening, which cannot be used.The same problem occurred.The other three directors of the same box in the same batch doctor refused to use it.However, there was no problem with the other batch numbers used later.The doctor thought that the same batch of goods would have the same problem and asked for replacement.
 
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Brand Name
SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 8FR X 25CM
Type of Device
SKATER
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 Key13506338
MDR Text Key288103082
Report Number0001625425-2022-00948
Device Sequence Number1
Product Code GBQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number756508025
Device Lot Number11338303
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/06/2022
Initial Date FDA Received02/10/2022
Supplement Dates Manufacturer Received02/06/2022
02/06/2022
Supplement Dates FDA Received03/31/2022
04/04/2022
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;
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