MAUDE Adverse Event Report: MENTOR TEXAS LAMIS 14GA X 23CM INFILTRATION CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Catalog Number	BN1423
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
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.A device history record review is in progress.Once completed, a supplemental report will be submitted.(b)(4).
Event or Problem Description
It was reported that prior to a unspecified surgery when a facility replaced a handle from a lamis 14ga x 23cm infiltration cannula, thinking it was the handle, the cannula started leaking more.There was no patient consequence reported.
Additional Manufacturer Narrative
On 3/20/2019, a manufacturing record evaluation (mre) was performed for the complaint device.As a result, the manufacturing date and expiration date fields have been updated.The manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).

• Brand Name: LAMIS 14GA X 23CM INFILTRATION CANNULA
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8367890
• Report Number: 1645337-2019-08843
• Device Sequence Number: 1097879
• Product Code: MUU
• UDI-Device Identifier: 00081317022534
• UDI-Public: 00081317022534
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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 Expiration Date: 03/10/2024
• Device Catalogue Number: BN1423
• Device Lot Number: 18090601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 04/01/2019
• Patient Sequence Number: 1