MAUDE Adverse Event Report: MENTOR TEXAS LAMIS 14GA X 30CM INFILTRATION CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Model Number	BN1430
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: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a lamis 14ga x 30cm infiltration cannula was found to be leaking near the hub preoperatively.There was no patient contact with the device, nor any reported procedural delays.
Additional Manufacturer Narrative
On 11-sep-2020, the investigation on the suspected medical device was completed based off of a provided photo.Investigation summary : upon visual evaluation of the image provided in the complaint, no apparent damage or visual anomalies were observed in the product.Since the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.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.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 14GA X 30CM INFILTRATION CANNULA
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10505112
• Report Number: 1645337-2020-11039
• Device Sequence Number: 11067021
• 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: 07/07/2022
• Device Model Number: BN1430
• Device Catalogue Number: BN1430
• Device Lot Number: 16121301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 09/14/2020
• Patient Sequence Number: 1