MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GELMARK ULTRACOR MARKER; BIOPSY INSTRUMENT

Catalog Number	GMUTC005T
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a mammography guide breast tissue marker placement procedure using the gelmark ultracor.On the post mammo images, the clip was not s shaped but linear in shape on several different mammo images.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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
On (b)(6) 2025, a patient underwent a mammography guide breast tissue marker placement procedure using the gelmark ultracor.It was noticed that, post the procedure on mammo images, the clip was not s shaped but linear in shape on several different mammo images.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.One mammogram image was provided and reviewed.The provide mammogram focuses on an area of interest that contains a post-biopsy breast tissue marker consistent with recent biopsy.As reported in the complaint, the marker does not demonstrate the expected shape of an s but rather is a small linear marker.Though the shape is different than what was anticipated, the marker appears to remain in 1 piece and is in its expected location at the biopsy site.Although the provided image shows a small linear marker, additional images are needed for confirmation; therefore, the reported event cannot be confirmed.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported device markings/labeling problem issues could not be determined based upon the provided information.Labeling review: a review of the breast tissue marker documents(baw1366100 rev 1) for the gel mark ultracor could not be completed because the required labels were missing.B5, d4 (medical device lot#, unique identifier (udi) #), g3, h6 (method).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.

• Brand Name: GELMARK ULTRACOR 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: 22792085
• Report Number: 2020394-2025-01240
• Device Sequence Number: 21029919
• Product Code: NEU
• UDI-Device Identifier: 00801741031908
• UDI-Public: (01)00801741031908(11)240916(17)251101(10)VTJW00465
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K040706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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 Expiration Date: 11/01/2025
• Device Catalogue Number: GMUTC005T
• Device Lot Number: VTJW00465
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2024
• 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