MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUGUIDE; BIOPSY INSTRUMENT

Catalog Number	C1813B
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	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a biopsy procedure using the magnum instrument.Prior to the procedure, a black hair was found in one sterile package, while a white fluff was noted in another sterile package.There were no reported injuries to the patient.
Event or Problem Description
On (b)(6) 2025, a patient underwent a biopsy procedure using the truguide instrument.Prior to the procedure, a black hair was found inside one sterile package, and a white fluff was observed in another sterile package.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: nine (9) truguide disposable coaxial biopsy needle packages were received for evaluation.The truguide disposable coaxial biopsy needle packages were randomly numbered for evaluation purposes.Upon visual evaluation, truguide disposable coaxial biopsy needle lot samples were received sealed within package.No anomalies were observed throughout each sealed lot samples.Therefore, the investigation is inconclusive for the reported device contamination with chemical or other material as original sample was not returned and only sealed samples were returned for evaluation which had no issues.A definitive root cause for the reported device contamination with chemical or other material 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.B5, d4 (unique identifier (udi) #), g3, h6 (method, result, conclusion) 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: TRUGUIDE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23036015
• Report Number: 2020394-2025-01483
• Device Sequence Number: 9514805
• Product Code: FCG
• UDI-Device Identifier: 00801741085024
• UDI-Public: (01)00801741085024(11)250124(17)271130(10)REJZ1712
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K936194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: C1813B
• Device Lot Number: REJZ1712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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