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

Model Number	121816
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
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: 01/2023).
Event or Problem Description
It was reported that during a biopsy, the device allegedly self-activated.There was no reported patient injury.
Event or Problem Description
It was reported that during a biopsy, the device allegedly self-activated.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.The sample appeared to be clean.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.The sample was functionally 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 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/apple for a total of 20 tests.The device was able to prime and fire.All samples were obtained.After the 10th test after the sample was taken from the sample notch the rotational knob was turned to fully prime the monopty and the device self-activated.The same issue occured after the 20th test.The device was disassembled and the internal parts were inspected.It was noted that the stylet and cannula hubs were from cavity.The inner housing #1 was from cavity 2.The inner housing#2 was from cavity 4.The outer housing was from cavity 2.The trigger was from cavity 1.There were no visual anomalies noted.Based on the findings, the investigation is confirmed for the reported self activation issue.A definitive root cause for the reported self activation issue 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: 01/2023),g3,h6(method).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.

• 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: 11964289
• Report Number: 2020394-2021-01198
• Device Sequence Number: 3724637
• Product Code: KNW
• UDI-Device Identifier: 00801741084645
• UDI-Public: (01)00801741084645
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 121816
• Device Catalogue Number: 121816
• Device Lot Number: REEP3371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/02/2021
• 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