MAUDE Adverse Event Report: MENTOR TEXAS HUNSTAD 12GA X 23CM INFILTRATION CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Model Number	BN1223H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
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 the tip was missing while cleaning hunstad 12ga x 23cm infiltration cannula but do no know for how long it was off.The device was not used on the patient.
Additional Manufacturer Narrative
On january 15, 2021, device evaluation was completed.Device evaluation summary: upon visual evaluation of the images provided in the complaint, it was noted that the tip was missing.As the product involved in this complaint was not received, the device could not be analyzed according to our procedures.On january 15, 2021, mentor became aware that lot number was provided in a photo but was inadvertently not reported under previous initial submission.Field d6 for lot number has been correctly updated to "17011803" on this form.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).Lot number was provided in a photo but was inadvertently not reported under previous initial submission.

• Brand Name: HUNSTAD 12GA X 23CM INFILTRATION CANNULA
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10971120
• Report Number: 1645337-2020-15610
• Device Sequence Number: 3240893
• Product Code: MUU
• UDI-Device Identifier: 00081317022473
• UDI-Public: 00081317022473
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: 08/09/2022
• Device Model Number: BN1223H
• Device Catalogue Number: BN1223H
• Device Lot Number: 17011803
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1