MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTRACOR; BREAST TISSUE MARKER

Model Number	SMUC10H
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2024).
Event or Problem Description
It was reported that during an ultrasound guided breast tissue marker placement procedure through normal density tissue, an mammogram examination demonstrated that the deployed marker alleged broken into two pieces in patient breast.There was no reported patient injury.
Additional Manufacturer Narrative
H10: this supplemental mdr is being submitted to report that mfr rpt# 2020394-2021-02119 was a duplicate record and was opened in error.The event details are being captured under complaint file # (b)(4) and was reported to the fda under mfr rpt# 2020394-2021-02086.H10: d4 (expiry date: 02/2024).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: device not returned.
Event or Problem Description
It was reported that during an ultrasound guided breast tissue marker placement procedure through normal density tissue, an mammogram examination demonstrated that the deployed marker alleged broken into two pieces in patient breast.There was no reported patient injury.

• Brand Name: SENOMARK ULTRACOR
• Common Device Name: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13092312
• Report Number: 2020394-2021-02119
• Device Sequence Number: 19882044
• Product Code: NEU
• UDI-Device Identifier: 00801741032394
• UDI-Public: (01)00801741032394
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K123911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: SMUC10H
• Device Catalogue Number: SMUC10H
• Device Lot Number: VTFP00127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female