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

Catalog Number	SMEC10C
Medical Device Problem Codes	Difficult to Insert (1316); Separation Failure (2547); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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: the physical sample was not returned for evaluation.Three electronic photos were provided and reviewed.Clip_1.Jpg photo shows the marker applicator.It is noted that the applicator is noted to be stretched with multiple kinks throughout.The distal tip of the applicator is noted to be detached and not within the photo.Clip_2.Jpg photo shows an unknown object that appears to have residue.The applicator is noted to the side of the object.Clip.Jpg photo shows a label of a senomark ultra; product information was verified with trackwise.Therefore, based on the photo review, the reported failures: difficult to insert and separation failure could not be confirmed based on the provided photos, so kept as inconclusive.The investigation is confirmed for the identified material detachment as the distal tip of the applicator is noted to be detached and also the investigation is confirmed for the identified material deformation as the applicator was noted be stretched with multiple kinks throughout.A definitive root cause for the reported difficult to insert issue, reported separation failure, identified material deformation and identified material detachment could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 11/2025) 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 a breast tissue marker placement procedure, the clip allegedly remained on the needle at the time of insertion.It was further reported that the clip was allegedly very difficult to be inserted and required a lot of force.Reportedly the clip remained inside the needle.There was no reported patient injury.

• 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: 19189430
• Report Number: 2020394-2024-00572
• Device Sequence Number: 8426261
• Product Code: NEU
• UDI-Device Identifier: 00801741032028
• UDI-Public: (01)00801741032028
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/24/2024

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 Catalogue Number: SMEC10C
• Device Lot Number: VTGY00728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• 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