MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK MARKER; BIOPSY INSTRUMENT

Model Number	SMTEC10G
Medical Device Problem Codes	Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one biopsy marker applicator was returned to evaluation.During visual evaluation, the device appeared to have residue and the wire-form and pva pads were not returned.On further evaluation it was noted that, marker applicator was returned in fully depressed condition and the distal tip of the device was noted to be broken.Functional testing was not performed due to the condition of the device.Therefore, the investigation is inconclusive for the reported difficult to insert issue, as functional testing was not performed.However, the investigation is confirmed for the identified detachment of device or device component, as distal tip of the marker applicator noted to be broken.Two electronic photos were provided and reviewed.First photo shows the needle applicator which appeared to be bloody.On further evaluation, it was noted that distal tip of the marker applicator noted to be broken.Second photo shows the mid portion of applicator which appears to be bloody.Therefore, based on the photo review, report difficult to insert issue could not be confirmed.However, the identified detachment of device or device component can be confirmed based on the first photo.A definitive root cause for the alleged difficult to insert and identified detachment of device or device component issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Expiry date: 07/2022.
Event or Problem Description
It was reported that during a breast biopsy procedure, the device allegedly difficult to insert to breast.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: SENOMARK MARKER
• Common Device Name: BIOPSY INSTRUMENT
• 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: 15162088
• Report Number: 2020394-2022-00634
• Device Sequence Number: 15071879
• Product Code: NEU
• UDI-Device Identifier: 00801741031977
• UDI-Public: (01)00801741031977
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2022

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: SMTEC10G
• Device Catalogue Number: SMTEC10G
• Device Lot Number: VTFQ00186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• 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