MAUDE Adverse Event Report: MENTOR TEXAS LAMIS 14GA X 15CM INFILTRATION CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Catalog Number	BN1406
Medical Device Problem Code	Fluid/Blood Leak (1250)
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 manufacturing record evaluation (mre) is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a lamis 14ga x 15cm infiltration cannula was leaking prior to surgery.After the handle was replaced by the facility, the cannula started leaking more.There were no patient consequences.
Additional Manufacturer Narrative
On 3/20/2019, a manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).

• Brand Name: LAMIS 14GA 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: 8355222
• Report Number: 1645337-2019-08701
• Device Sequence Number: 2197970
• Product Code: MUU
• UDI-Device Identifier: 00081317022527
• UDI-Public: 00081317022527
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K981172
• 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: 09/23/2023
• Device Catalogue Number: BN1406
• 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: 02/20/2019
• Supplement Report FDA Received Date: 04/10/2019
• Patient Sequence Number: 1