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

Model Number	121816
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	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 disposable core biopsy instrument was returned for evaluation.During visual evaluation, the sample appeared to be clean, and the device was returned in their initial position.Upon functional testing, the device is functionally tested by cocking and firing the device 20 times into an apple for a total of 20 tests.The device was able to prime and fire.When priming the device for the 7th, 9th and 11th test the cannula self-activated and the stylet remained primed.The actuator trigger was then pressed, and the stylet fired.Then the device was disassembled, and the internal parts were inspected.It was noted that the stylet hub was from cavity 1 and the cannula hub was from cavity 1.Upon dimensional evaluation, the cannula outer tang width and stylet outer tang width was not within the acceptable range.Therefore, the investigation is inconclusive for the reported failure to prime, as priming attempts were not successfully completed due to the self-activation.However, the investigation is confirmed for the identified self-activation, as the device self-activated while priming.However, the definitive root cause could not be determined based upon available 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.Expiry date: 12/2022.
Event or Problem Description
It was reported that prior to a kidney biopsy procedure, the device allegedly failed to prime.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 85281
• MDR Report Key: 12148957
• Report Number: 2020394-2021-01303
• Device Sequence Number: 3910316
• 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
• Report Date (Section B): 06/17/2021

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: REEZ2556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/12/2021
• 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