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

Catalog Number	SMEC10R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be 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.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.
Event or Problem Description
It was reported that post a breast tissue marker placement, the patient experienced an anaphylactic allergy to polyethylene glycol and was administered adrenaline.It was further reported that the physician planned to remove the marker and the polyglycolic acid pads.However, the current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.Two electronic photos were provided and it was reviewed.The first photo shows some tissues which is in a dried condition in a white paper.The second photo shows the same tissues and it was presented in a ultrasound images on a monitor.Based on the provided photos, the reported allergic reaction cannot be confirmed.Therefore, the investigation is inconclusive for the reported allergic reaction as the cause of the allergic reaction cannot be determined.A definitive root cause for the reported adverse event without identified device or use problem 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.H11: section a through f ¿ the information provided by bd represents all 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.
Event or Problem Description
It was reported that post a breast tissue marker placement, the patient allegedly experienced an anaphylactic allergy to polyethylene glycol and was administered adrenaline.It was further reported that the physician planned to remove the marker and the polyglycolic acid pads.However, the current status of the patient is unknown.

• 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: 20221878
• Report Number: 2020394-2024-01422
• Device Sequence Number: 7328718
• Product Code: NEU
• UDI-Device Identifier: 00801741032035
• UDI-Public: (01)00801741032035
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SMEC10R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 12/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female