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

Model Number	121410
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records 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: 11/2022).
Event or Problem Description
It was reported that during a biopsy procedure, the device allegedly self-activated when it was rotated twice.There was no reported patient injury.
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: one monopty disposable core biopsy instrument was returned for evaluation.During visual evaluation, the device appeared to be clean and was received in its initial position.Upon functional testing, the device was tested by twisting the rotational knob once and the cannula retracted and locked into place.The rotational knob was turned once more and the stylet retracted.The device was able to be fully primed.The device was functionally tested by cocking and firing the device 20 times into a chicken breast for a total of 20 tests.After fully priming, for the 4th test the device self activated.Therefore, the investigation is confirmed for the reported self-activation as the device self-activated during functional test.A definitive root cause for the alleged self-activation could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 11/2022).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.H3 other text : see h10.
Event or Problem Description
It was reported that during a biopsy procedure, the device allegedly self-activated when it was rotated twice.There was no reported patient injury.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12478956
• Report Number: 2020394-2021-01689
• Device Sequence Number: 4345679
• Product Code: KNW
• UDI-Device Identifier: 00801741084584
• UDI-Public: (01)00801741084584
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133948
• 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): 11/02/2021

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: REEZ2573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2021
• 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