MAUDE Adverse Event Report: AMBU A/S AMBU NEUROLINE CONCENTRIC

Catalog Number	74025-30/25
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are unable to verify the needle fall off from the hub as there is no complaint sample returned.Furthermore, we are also unable to verify the reported failure from the retention sample.It is highly suspected that the cause of the needle (cannula) fall off is due to excessive force induced during application and in combination with multiple wide angle bending.
Event or Problem Description
During a routine needle electromyography (emg) procedure, while examining the left iliopsoas muscle, the concentric needle broke off of the needle hub.This incident occurred during the portion of the motor unit activation exam, where the hip is flexed upwards with the needle in the muscle.The adipose tissue there require deeper penetration of the needle.The patient did not report discomfort.X-ray revealed evidence of the needle fragment present in the proximal left thigh.Patient was evaluated at a local emergency room (er) where no urgent action was required.Patient is awaiting urgent outpatient surgery evaluation for removal of the foreign object.

• Brand Name: AMBU NEUROLINE CONCENTRIC
• Common Device Name: AMBU NEUROLINE CONCENTRIC
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU SDN.BHD; lintang bayan lepas, phase iv; lot 69-b; penang, 11900 0; MY 119000
• Manufacturer Contact: cecilie bjergen ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 16282582
• Report Number: 9610691-2023-00004
• Device Sequence Number: 6766620
• Product Code: IKT
• UDI-Device Identifier: 05707480022878
• UDI-Public: 05707480022878
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K071186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/02/2023

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 Expiration Date: 03/03/2025
• Device Catalogue Number: 74025-30/25
• Device Lot Number: 1000652154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male