MAUDE Adverse Event Report: MENTOR TEXAS BECKER TEAR DROP 5MM X 26CM LARGE HANDLE CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Model Number	BECTD526L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	01/15/2020
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: na.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a cannula (26cm lg; becker tear drop 5mm x 26cm large handle cannula) broke at the hub.There was no adverse event or patient consequences.No further information was provided.
Additional Manufacturer Narrative
On 3/17/2020, photo evaluation was completed.Upon visual inspection of the picture, it was observed that the hub of the cannula was broken.The photos do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 3/10/2020, 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 3/11/2020, mentor became aware that (b)(6) was mistakenly reported as the serial number in the initial submission.It is the lot number and has been corrected on this form.Manufacturer¿s reference number: (b)(4).

• Brand Name: BECKER TEAR DROP 5MM X 26CM LARGE HANDLE CANNULA
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9687077
• Report Number: 1645337-2020-02061
• Device Sequence Number: 16973967
• Product Code: MUU
• UDI-Device Identifier: 00081317020783
• UDI-Public: 00081317020783
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/17/2020

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: 07/14/2024
• Device Model Number: BECTD526L
• Device Catalogue Number: BECTD526L
• Device Lot Number: 19011501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 03/10/2020; 03/17/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/11/2020; 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1