MAUDE Adverse Event Report: MEDAX SRL UNIPERSONALE MEDEASY; INSTRUMENT, BIOPSY

Model Number	ML18080-K0
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of chronic obstructive pulmonary disease and increasing shortness of breath was admitted for a soft-tissue right breast biopsy.Prior to inserting needle into patient, the medax srl unipersonale medeasy soft tissue semi-automatic biopsy needle 18g x 80 mm (lot # 06186-20, ref # ml18080-ko) came unglued.The defective needle was never placed into the patient.Another of the same type and lot # of that needle was opened and used.This is not the first event for this product, reported same incident with this type of device in the recent past.

• Brand Name: MEDEASY
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MEDAX SRL UNIPERSONALE; 2769 mc cracken lane; castle rock CO 80104
• MDR Report Key: 11964806
• Report Number: 11964806
• Device Sequence Number: 3193985
• Product Code: KNW
• UDI-Device Identifier: 08054301667419
• UDI-Public: (01)08054301667419(17)250401(11)200501(10)06186-20
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/27/2021
• Report Date (Section F): 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ML18080-K0
• Device Catalogue Number: ML18080-K0
• Device Lot Number: 06186-20
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2021
• Patient Sequence Number: 1
• Patient Weight: 54
• Date Report Sent to FDA: 05/27/2021