MAUDE Adverse Event Report: NERIA; NERIA STEEL G27 60/8

Model Number	78-060-2738
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During quality review process, unomedical has captured this incident and deemed it reportable.Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that the extension which fixes the needle had disconnected itself.Therefore, it occurred a leakage of the treatment liquid.Upon visual inspection performed on the returned used device (one tubing), it was found that the tubing was detached from the tubing connector (missing glue).No further information available.

• Brand Name: NERIA
• Common Device Name: NERIA STEEL G27 60/8
• MDR Report Key: 11768252
• Report Number: 3003442380-2021-00238
• Device Sequence Number: 3104674
• Product Code: FPA
• UDI-Device Identifier: 05705244001572
• UDI-Public: 05705244001572
• Combination Product (Y/N): Y
• PMA/510(K) Number: K945617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: No Information
• Device Expiration Date: 10/01/2022
• Device Model Number: 78-060-2738
• Device Lot Number: 5207746
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 05/04/2021
• Patient Sequence Number: 1