MAUDE Adverse Event Report: ARGON MEDICAL DEVICES PRO-MAG BIOPSY NEEDLE 18GA X 20CM

Model Number	765018200
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.
Event or Problem Description
The needle notch is not smooth and it is bent so the operator said he couldn't harvest high quality histological specimens and some of the specimens were crushed and not completed.
Additional Manufacturer Narrative
H3 other text: placeholder.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
H3 other text: placeholder.

• Brand Name: PRO-MAG BIOPSY NEEDLE 18GA X 20CM
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11340747
• Report Number: 1625425-2021-00851
• Device Sequence Number: 17184294
• Product Code: FCG
• UDI-Device Identifier: 00886333006922
• UDI-Public: 00886333006922
• Combination Product (Y/N): N
• PMA/510(K) Number: K980226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/17/2021

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: 01/06/2025
• Device Model Number: 765018200
• Device Catalogue Number: 765018200
• Device Lot Number: 11290046
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/12/2021; 04/15/2021; 04/26/2021
• 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