MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT 16GA X 9CM

Model Number	701116090
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A facility reported that during a bone biopsy procedure, the needle became totally disconnected from the hub during the acquisition of a sample.This resulted in a large blood spray covering the physician and equipment.There was no patient injury.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.10.After three notifications, no product was returned for evaluation.An image of the device was provided.The image showed the device split distally, and the complaint was confirmed.Without the actual device the examine, a definitive root cause could not be determined.A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.Argon is currently exploring options to mitigate the possiblity of recurrence of this issue.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.There have been no other complaints reported in the lot.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT 16GA X 9CM
• Common Device Name: SUPERCORE BIOPSY INSTRUMENT
• 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: 18793159
• Report Number: 0001625425-2024-00938
• Device Sequence Number: 12849893
• Product Code: KNW
• UDI-Device Identifier: 00886333005918
• UDI-Public: (01)00886333005918(17)280803(10)11491096
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974814
• 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,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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 701116090
• Device Lot Number: 11491096
• Was Device Available for Evaluation?: Yes
• 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: 01/30/2024
• Supplement Date Received by Manufacturer: 04/17/2024; 08/31/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 05/13/2024; 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown