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 Code	No Patient Involvement (2645)
Date of Event	07/31/2020
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: na.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a lamis 16ga x 15cm infiltration cannula was found to be leaking at the hub by the end user.The device was not in use at the time, and there was no reported patient involvement.
Additional Manufacturer Narrative
On october 12, 2020, photo evaluation was completed.Upon visual evaluation of the image provided in the complaint, no apparent damage or visual anomalies were observed and no leakage was observed from the hub.A manufacturing record evaluation (mre) was performed, 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).
Additional Manufacturer Narrative
On august 31, 2020, mentor became aware that field g5 for "pma/ 510(k)" was inadvertently left blank under the previous initial submission.It has been updated on this form.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: 10459799
• Report Number: 1645337-2020-10662
• Device Sequence Number: 2391439
• Product Code: MUU
• UDI-Device Identifier: 00081317022565
• UDI-Public: 00081317022565
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 08/14/2020

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: 03/05/2024
• Device Model Number: BN1606
• Device Catalogue Number: BN1606
• Device Lot Number: 18083001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 08/31/2020; 10/12/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 08/31/2020; 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1