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

Model Number	1410MSK
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd (b)(4).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 mission disposable core biopsy instrument was returned for evaluation.On visual evaluation, the device appeared clean and the device was returned in initial configuration with the cannula at the 00 mm position and the sample notch was not exposed.On further visual evaluation, the two proximal tangs from the upper case half were noted to be bent inwards and not secured against lower case half.On functional evaluation the device was fully primed with no issues.On further evaluation, the device was dry fired and the gap was noted between the upper and lower case halves.Due to the condition of the device, functional testing was not performed.Therefore, the investigation for the identified detachment is confirmed as the proximal tangs of the upper case half was noted to bent inwards and not secured against the lower case half.However, the investigation for the reported failure to fire is kept as inconclusive as the functional testing was not performed.Identified detachment may contributed to the reported issue.However, a definitive root cause for the alleged failure to fire and identified detachment 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.(expiry date: 07/2023).
Event or Problem Description
It was reported that prior to an ultrasound guided breast biopsy procedure, the device allegedly failed to fire.A coaxial needle was used.There was no patient contact.

• Brand Name: MISSION
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14110439
• Report Number: 2020394-2022-00296
• Device Sequence Number: 5276744
• Product Code: KNW
• UDI-Device Identifier: 00801741142543
• UDI-Public: (01)00801741142543
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K171953
• 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
• Report Date (Section B): 03/19/2022

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: 1410MSK
• Device Catalogue Number: 1410MSK
• Device Lot Number: 0001378975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/14/2022
• 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: Female