MAUDE Adverse Event Report: SONOTAP; PERIPHERAL NEEDLE

Model Number	1185-3E050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6).As soon as further information becomes available, an updated follow up report will be sent in to the agency.
Event or Problem Description
Irn# (b)(4).Needle broken at the hub, the needle body remained in the patient's arm.Surgeon was called in.
Additional Manufacturer Narrative
Event took place in france.As soon as further information becomes available, an updated follow up report will be sent in to the agency.Based on risk assessment and clinical assessment case is considered as closed.
Event or Problem Description
Irn# (b)(4).Needle broken at the hub, the needle body remained in the patient's arm.Surgeon was called in.

• Brand Name: SONOTAP
• Common Device Name: PERIPHERAL NEEDLE
• MDR Report Key: 11234661
• Report Number: 9611612-2021-00003
• Device Sequence Number: 17236127
• Product Code: BSP
• UDI-Device Identifier: 14048223021214
• UDI-Public: 14048223021214
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 09/21/2025
• Device Model Number: 1185-3E050
• Device Catalogue Number: 1185-3E050
• Device Lot Number: 1366
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 04/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2020
• 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; Required Intervention