MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MISSION KIT 20G X 10CM; BIOPSY INSTRUMENT

Model Number	2010MSK
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of seven for this event.The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is (b)(4).As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 11/2024).
Event or Problem Description
It was reported that prior to a biopsy procedure, the wrong size coaxial needle was allegedly given in the package.There was no patient contact.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: as this malfunction is considered one event; only one mdr report will be submitted for the reported quantity affected of seven for this event.H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.H10: d4 (expiry date: 11/2024).H11:section a through f - the information provided by bd represents all of 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 : device not returned.
Event or Problem Description
It was reported that prior to a biopsy procedure, the coaxial allegedly not fit with the needles in their mission kit.There was no patient contact.

• Brand Name: MISSION KIT 20G X 10CM
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13868668
• Report Number: 2020394-2022-00207
• Device Sequence Number: 12078428
• Product Code: KNW
• UDI-Device Identifier: 00801741097089
• UDI-Public: (01)00801741097089
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2022

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: 2010MSK
• Device Catalogue Number: 2010MSK
• Device Lot Number: 0001445946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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