MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER SINGLE STEP DRAINAGE SET 6FR X 25CM

Model Number	756006025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
¿tip of the puncture needle broke off during the puncture¿.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.Evaluation summary: a review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.The customer did not return any samples for evaluation.Additionally, no photographic or visual evidence was submitted that would have allowed this allegation to be reviewed.Without the necessary evidence, a thorough investigation cannot be performed.Determining a root cause and corrective action is not possible.If the samples are returned at a later date, then this complaint may be reopened for re-evaluation.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: SKATER SINGLE STEP DRAINAGE SET 6FR X 25CM
• Common Device Name: SKATER SINGLE STEP DRAINAGE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19242442
• Report Number: 0001625425-2024-01008
• Device Sequence Number: 12504667
• Product Code: GBQ
• UDI-Device Identifier: 00886333000227
• UDI-Public: (01)00886333000227(17)270615(10)11422155
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 756006025
• Device Lot Number: 11422155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 08/31/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 06/21/2024; 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown