MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER BILIARY DRAINAGE CATHETER LOCKING PIGTAIL WITH RADIOPAQUE BAND 8F X 40CM

Model Number	755308040
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.
Event or Problem Description
The patient had been intubated for 4 days, and the drainage tube broke when it was removed.
Additional 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.According to the product experience report, there was no sample to be returned.However, photo evidence does show that the skater has separated at the radiopaque site.The wheeling quality manager has been notified of this issue, and will determine an appropriate corrective action.
Event or Problem Description
The patient had been intubated for 4 days, and the drainage tube broke when it was removed.

• Brand Name: SKATER BILIARY DRAINAGE CATHETER LOCKING PIGTAIL WITH RADIOPAQUE BAND 8F X 40CM
• Common Device Name: 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 Key: 13767385
• Report Number: 0001625425-2022-00958
• Device Sequence Number: 1982485
• Product Code: FGE
• UDI-Device Identifier: 00886333006113
• UDI-Public: 00886333006113
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2022

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 Expiration Date: 09/22/2025
• Device Model Number: 755308040
• Device Catalogue Number: 755308040
• Device Lot Number: 11328589
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown