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

Catalog Number	121620
Medical Device Problem Codes	Break (1069); Self-Activation or Keying (1557); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one monopty biopsy needle was received for evaluation.During visual evaluation, the device appeared to be clean.The monopty disposable core biopsy instrument was received in second rotational position with the arrow in the ready window.The distal tip of the stylet was not observed to be protruding from the distal end of the cannula.The actuator button was noted to be dislodged within the rotational knob.A gap was noted to the rotational knob.Due to the nature of the complaint, no functional testing was performed.Upon dimensional observation, the stylet tang width was measured, and the measurement is not within specification.The device was received and remained in its second rotational position for an extended period.The stylet tang width was measured below specification.Prolonged compression in the primed state may have contributed to dimensional changes post-manufacture, potentially leading to the observed self-activation.Disassembly confirmed no molding defects in the stylet tangs.Therefore, the investigation is unconfirmed for the reported break as no break has been observed.However, the investigation is confirmed for the identified device dislodged or dislocated as the actuator button was dislodged from the green inner handle.And the investigation is confirmed for the identified self-activation as the cannula is noted to be initial position while the stylet remained primed.A definitive root cause for the reported break, identified device dislodged or dislocated and identified self-activation issues 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.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 biopsy procedure using the monopty device, upon opening the needle box, the instrument body was broken.Another cannula needle was used to complete the procedure.There was no patient contact.

• Brand Name: MONOPTY
• 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: 23399703
• Report Number: 2020394-2025-01787
• Device Sequence Number: 10179538
• Product Code: KNW
• UDI-Device Identifier: 00801741084621
• UDI-Public: (01)00801741084621(17)250731(10)REGV3636
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133948
• 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
• Report Date (Section B): 10/21/2025

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 Expiration Date: 07/31/2025
• Device Catalogue Number: 121620
• Device Lot Number: REGV3636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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