MAUDE Adverse Event Report: MENTOR TEXAS LOCAL CNULA 14GA 30CM LAMIS; SYSTEM, SUCTION, LIPOPLASTY

Model Number	BN1430
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a lamis 14ga x 30cm infiltration cannula was broken at the hub and developed a leak pre-operatively.There was no patient involvement, no adverse event reported.
Additional Manufacturer Narrative
On (b)(6) 2020, a manufacturing record evaluation was performed for the finished device 16042902 number, and no non-conformance's were identified.Manufacturer¿s reference number: (b)(4).

• Brand Name: LOCAL CNULA 14GA 30CM LAMIS
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10469606
• Report Number: 1645337-2020-10776
• Device Sequence Number: 19451820
• Product Code: MUU
• UDI-Device Identifier: 00081317022541
• UDI-Public: 00081317022541
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 11/29/2021
• Device Model Number: BN1430
• Device Catalogue Number: BN1430
• Device Lot Number: 16042902
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 08/29/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1