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

Model Number	121410
Medical Device Problem Codes	Failure to Prime (1492); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 07/2022).
Event or Problem Description
It was reported that prior to an ultrasound-guided breast biopsy procedure through normal density tissue, the device allegedly failed to prime.The procedure was completed using another device.There was no patient contact.
Event or Problem Description
It was reported that prior to an ultrasound-guided breast biopsy through normal density tissue, the device allegedly failed to prime.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required investigation summary: one biopsy needle was returned for the evaluation.Visual evaluation was performed and noted that device appeared to be clean and was received with protective tubing.The stylet and cannula were in their initial positions, as the arrow could not be seen in the ready window.There were no visual anomalies noted on the device.During the functional test, the rotational knob was turned and the stylet retracted as expected.The device was able to be fully primed with no issues and the arrow was visible in the ready window.The device was functionally tested by cocking and firing the device 20 times into a chicken breast for a total of 20 tests.The device was able to prime and fire properly for 15 tests, on the 16th test when the device was primed the device self-activated before the rotational knob could allow the stlyet to lock into place.The device was disassembled and the internal parts were inspected.It was noted that the stylet and cannula hubs were from cavity 2.The inner housing #1 was from cavity 3.The inner housing#2 was from cavity 4.The outer housing was from cavity 1.The trigger was from cavity 2.Therefore, the investigation is confirmed for the reported failure to prime as device self activated while priming.The investigation is also confirmed for the identified self activation issue, as device self activated during the functional test.A definitive root cause for the reported failure could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 07/2022), g3 h11: h6 (result, conclusion) 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.

• Brand Name: MONOPTY
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11221986
• Report Number: 2020394-2020-21116
• Device Sequence Number: 11732156
• Product Code: KNW
• UDI-Device Identifier: 00801741084584
• UDI-Public: (01)00801741084584
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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 Model Number: 121410
• Device Catalogue Number: 121410
• Device Lot Number: REDV2265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other