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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 7FR X 25CM
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ARGON MEDICAL DEVICES SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 7FR X 25CM Back to Search Results
Catalog Number 756507025
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2020
Event Type  malfunction  
Manufacturer Narrative
A review of the device found the string was broken, confirming the complaint.The cause was most likely due to the separation of the pigtails during assembly, or the string was detached prior to packaging and was missed during the final inspection.The supervisor of the area has been notified of this issue and argon will continue to monitor and trend for instances of a similar nature in the future.
 
Event Description
Wire break.
 
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Brand Name
SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 7FR X 25CM
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 Key10290015
MDR Text Key199991405
Report Number1625425-2020-00421
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 distributor
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 07/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number756507025
Device Lot Number11292566
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2020
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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