MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL-PURPOSE AND NEPHROSTOMY DRAINAGE SET NON-LOCKING 6F X 20CM

Model Number	756106020
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drainage catheter broke at the white hub, due to the leak the patient had a pneumothorax.Connecting tube 404343015, lot 11410970.Report for this item has been provided as well.
Additional Manufacturer Narrative
It is unknown if the sample will get returned for evaluation or not.Customer was notified to let manufacturer know about sample status.A follow- up report will be submitted once more information is available.
Event or Problem Description
Drainage catheter broke at the white hub, due to the leak the patient had a pneumothorax.Connecting tube 404343015, lot 11410970.Report for this item has been provided as well.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.A review of returned product from the customer was performed.Sample was visually inspected and found drainage tube breakage/separated from the hub.Customer returned drainage hub and drainage tube.Drainage tube length was 1.8cm and drainage tube breakage was 2mm from printed 6f mark (product identification).According to the drawing, te400137ma mark is 15mm +/- 0.5mm from the drainage hub.Most likely drainage tube's one piece was missing (between the hub and the returned drainage tube).During the evaluation, it was identified that drainage tube did not break, drainage tube was cut from the drainage hub and the complaint was confirmed.A conclusive root cause could not be determined.A possible root cause for the complaint could be user error.Most likely user accidentally cut the tube.No corrective action is required at this time because a manufacturing defect could not be confirmed.

• Brand Name: SKATER ALL-PURPOSE AND NEPHROSTOMY DRAINAGE SET NON-LOCKING 6F X 20CM
• 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: 15536294
• Report Number: 0001625425-2022-01105
• Device Sequence Number: 5256019
• Product Code: GBQ
• UDI-Device Identifier: 00886333225477
• UDI-Public: 00886333225477
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 756106020
• Device Catalogue Number: 756106020
• Device Lot Number: 11406234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown