MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT 18GA X 15CM

Model Number	701118150
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned for evaluation.The device body was found to have split apart, the lock tabs were damaged, confirming the complaint.(b)(4) was initiated to mitigate locking tab breakage on the supercore device.
Event or Problem Description
Patient: infectious disease patient, pyogenic spondylitis event description: the device was opened for a spine biopsy procedure.The supercore was test fired once.Then the needle was inserted into the patient, however, the physician noticed that he had forgot to lock the plunger in ready position.The needle was removed and when the plunger was pulled to lock, with normal force, the plunger came off the housing with the stylet needle and separated.At that time by the unpredictable movement, the physician got pricked his left palm with the separated stylet needle.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT 18GA X 15CM
• Common Device Name: SUPERCORE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 creek rd; athens TX 75751
• MDR Report Key: 12175898
• Report Number: 0001625425-2021-01026
• Device Sequence Number: 1323194
• Product Code: KNW
• UDI-Device Identifier: 00886333005888
• UDI-Public: 00886333005888
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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 Expiration Date: 06/15/2025
• Device Model Number: 701118150
• Device Catalogue Number: 701118150
• Device Lot Number: 11314656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/15/2021
• 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