MAUDE Adverse Event Report: MENTOR TEXAS BECKER TEAR DROP 3MM X 26CM LARGE HANDLE CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Model Number	BECTD326L
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a becker tear drop 3mm x 26cm large handle cannula was being utilized in an unspecified procedure.During the procedure one of the three prongs became bent and broke off of the device.No patient consequences or delays during the procedure were reported.The device was discarded and a replacement was ordered.
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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 08, 2022, mentor completed a manufacturing record evaluation on the reported device.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.It is also to be reported that the lot number was updated as 21040601 per the manufacturing record evaluation.Manufacturer¿s reference number: (b)(4).D4.Lot: 21040601.

• Brand Name: BECKER TEAR DROP 3MM X 26CM LARGE HANDLE CANNULA
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13481138
• Report Number: 1645337-2022-01151
• Device Sequence Number: 5363666
• Product Code: MUU
• UDI-Device Identifier: 00081317020752
• UDI-Public: 00081317020752
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K981172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Model Number: BECTD326L
• Device Catalogue Number: BECTD326L
• Device Lot Number: 21040601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown