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

Model Number	SMEC10R
Medical Device Problem Codes	Break (1069); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that post breast tissue marker placement procedure, the device allegedly broken.There was no reported patient injury.
Event or Problem Description
It was reported that post breast tissue marker placement procedure, a plastic segment like marker pellets allegedly came out when the needle was removed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one encor biopsy probe, senomark biopsy marker applicator, removable probe cover and partial vacuum assembly were returned for evaluation.On visual evaluation, the probe was received with a tip guide and the marker was returned inserted into the sample chamber.And it was further noted that the plunger was fully depressed and it was noted that the red indicator on the probe and the yellow indicator on the marker applicator were aligned.And it was further noted that the probe appeared to have residue throughout.Foreign like material was noted within the package and the material had blood residue.On additional evaluation, senomark applicator was removed from the encor probe and upon microscopic visual observation, no damage was noted to the distal tip of the applicator and the pusher rod was noted within the applicator.One electronic photo was provided for review.Photo shows the package where small marker pellet substance was present inside and it was noted to have blood residue.However, it is not clearly visible whether it is foreign component or marker pellet.Therefore, based on the photo review, the reported failure device contamination could not be confirmed.Therefore, the investigation for the reported device contamination is kept as inconclusive as there were no proper evident provided.(i.E.Based on the photo review).Additionally, ftir analysis of noted foreign like material was conducted.It showed good correlation with the poly (ethylene oxide).And it was further noted that the material which is noted to be foreign is consistent with the material which was used to manufacture peg pellets, which is usually for preventing marker migration(i.E post deployment) and gets dissolves into the body.And it was concluded that the material was not considered to be foreign.And another material found in the cutter of the encor probe was undergone ftir analysis which shows the mixture of human components (i.E skin/nail/keratin) as well as contribution from a salt substance.The device was used on patient therefore we cannot confirm whether saline is used during the procedure or not.Therefore, based on the sample analysis and the ftir analysis, the reported device contamination can be unconfirmed as the return material is consistent with the material manufactured for the peg pellets.A definitive root cause for the alleged device contamination 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.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.

• Brand Name: SENOMARK ULTRA BREAST TISSUE 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: 15742418
• Report Number: 2020394-2022-00870
• Device Sequence Number: 14791057
• Product Code: NEU
• UDI-Device Identifier: 00801741032035
• UDI-Public: (01)00801741032035
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 11/29/2022

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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