MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACOR TWJAVASCRIPT:TABCLICKED(11)IRL MARKER; BREAST TISSUE MARKER

Catalog Number	UCTW17
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a breast tissue marker placement procedure, there was a hair allegedly found inside the packaging.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H11: section a through f: the information provide 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.
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 device was not returned for evaluation.One electronic photo was provided and reviewed.The photo shows ultracor twirl marker packaging and a hair like substance was noted within the sealed packaging.Based on the photo review the reported event can be confirmed.Therefore, the investigation is confirmed for the reported device contamination with chemical or other material as a hair like substance was noted within the sealed packaging.A definitive root cause for the reported device contamination with chemical or other material issue 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: g3, h6 (method).H11: d4 (unique identifier (udi) #), h6 (result, conclusion).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 during a breast tissue marker placement procedure, there was a hair allegedly found inside the packaging.There was no reported patient injury.

• Brand Name: ULTRACOR TWJAVASCRIPT:TABCLICKED(11)IRL MARKER
• Common Device Name: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20785149
• Report Number: 2020394-2024-01742
• Device Sequence Number: 20096817
• Product Code: NEU
• UDI-Device Identifier: 00801741109416
• UDI-Public: (01)00801741109416(11)240301(17)261228(10)HUJN1045
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K180061
• 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): 02/18/2025

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: UCTW17
• Device Lot Number: HUJN1045
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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