MAUDE Adverse Event Report: MENTOR TEXAS LAMIS 16GA X 15CM INFILTRATION CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Model Number	BN1606
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a cannula was leaking fluid.There was no adverse event or patient consequences.No further information was provided.
Additional Manufacturer Narrative
On may 28, 2020, the photo investigation was completed.Photo investigation summary: upon visual evaluation of the image provided in the complaint, it is not possible to observe leakage in the cannula.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer's reference number: (b)(4).

• Brand Name: LAMIS 16GA X 15CM INFILTRATION CANNULA
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9583560
• Report Number: 1645337-2020-00744
• Device Sequence Number: 458070
• Product Code: MUU
• UDI-Device Identifier: 00081317022565
• UDI-Public: 00081317022565
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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: BN1606
• Device Catalogue Number: BN1606
• Device Lot Number: 140311
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1