MAUDE Adverse Event Report: MENTOR TEXAS SATTLER 3MM X 23CM LUER LOCK CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Catalog Number	BNSAT323
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2018
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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that the tip of a sattler 3mm x 23cm luer lock cannula broke off.The event did not cause injury to a patient or user.There was no patient consequence.
Additional Manufacturer Narrative
On 04/09/2019, 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.On 04/24/2019, mentor completed the investigation on the suspect medical device.It was not possible to perform a proper product investigation since the device was not returned.Nonetheless, the customer provided a photo of the actual cannula involved in the complaint.Based on the photo, the tip of the cannula is totally broken and fully separated.The complaint was confirmed.Manufacturer¿s reference number: (b)(4).

• Brand Name: SATTLER 3MM X 23CM LUER LOCK CANNULA
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8118057
• Report Number: 1645337-2018-07131
• Device Sequence Number: 19241875
• Product Code: MUU
• UDI-Device Identifier: 00081317020851
• UDI-Public: 00081317020851
• 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): 11/12/2018

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: 06/27/2021
• Device Catalogue Number: BNSAT323
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 04/24/2019
• Patient Sequence Number: 1