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

Model Number ML18080-K0

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2021

Event Type  malfunction  

Event Description

An upper-middle aged female with history of coronary artery disease, factor v leyden mutation, and hypertension, presented to emergency dept with abdominal pain.Having an ultrasound biopsy of abdominal core.After inserting into the patient, the biopsy needle was not firmly attached to the plastic base.Device removed and a replacement was used.No known harm to the patient.Device was not saved.

• Brand Name: MEDEASY
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MEDAX SRL UNIPERSONALE; via r. piva 1/a; poggio rusco, mantova it 46025
• MDR Report Key: 11574113
• MDR Text Key: 242435322
• Report Number: 11574113
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 08054301667419
• UDI-Public: (01)08054301667419(17)250401(11)200501(10)06186-20
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ML18080-K0
• Device Lot Number: 06186-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Weight: 104