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

Model Number	SMEC10R
Medical Device Problem Codes	Component Missing (2306); Separation Failure (2547); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ultrasound guided breast marker placement procedure, the marker failed to release into the cavity and came along with the needle.The procedure was completed using another device.There was no reported patient injury.
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 senomark ultra biopsy marker applicator, tip guide, tip protector and partial pga pads were returned for evaluation.Upon visual evaluation, the device appeared to have blood residue throughout.The applicator was returned with the plunger fully depressed.Partial pad was noted within the applicator.Upon functional testing, an attempt to deploy the returned pads however it was unsuccessful, the plunger appeared to not touch the pad.The biopsy applicator was x-rayed, and it was noted the marker was not present.Upon additional evaluation, the plastic tip of the plunger assembly was missing from plunger assembly and the peg push pellet was not within the marker applicator.The shorter length plunger rod would have contributed to the deployment issues, as the plunger would not have been able to fully press the pads out of the applicator.Therefore, the investigation is confirmed for the reported separation failure and identified component disassembled, component missing as the plastic tip of the plunger assembly was missing from plunger assembly and the peg push pellet was not within the marker applicator.A definitive root cause for the alleged separation failure and identified component disassembled, component missing is determined to be manufacturing related 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: 04/2024).

• Brand Name: SENOMARK ULTRA
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14083528
• Report Number: 2020394-2022-00287
• Device Sequence Number: 20146495
• Product Code: NEU
• UDI-Device Identifier: 00801741032035
• UDI-Public: (01)00801741032035
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123911
• 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): 03/15/2022

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: SMEC10R
• Device Catalogue Number: SMEC10R
• Device Lot Number: VTFR00258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• 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: Unknown