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

Catalog Number	1820MSK
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a biopsy procedure, the coaxial needle in the kit allegedly was not compatible with the biopsy needle.It was further reported that the internal diameter of the coaxial cannula allegedly may be smaller or larger than the external diameter of the biopsy needle.There was no patient contact.
Additional Manufacturer Narrative
H10: a voluntary recall has been initiated for mission disposable core biopsy instrument kit which are product catalog/lot number specific.Reportedly the mission disposable core biopsy instrument kit may have a mismatch between the coaxial and the needle in the kit devices.Device incompatibility due to the external diameter of the biopsy instrument being larger than the internal diameter of the coaxial needle is most likely to result in no patient involvement or a clinically insignificant procedural delay.If the coaxial needle has been deployed, an additional device would be required.If a compatible device is not immediately available, the procedure may need to be repeated, resulting in minor injury from a new needle puncture and care may be prolonged.If efforts are made to use the device despite incompatibility, unusual adverse events such as needle tip breakage may occur.To date there have been no adverse events worldwide reported related to this issue.As result of the field action, this event is being reported as a malfunction reportable event.H10: 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.H10: d4 (expiration date: 03/2025).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.

• Brand Name: MISSION KIT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): CAREFUSION D.R. 203 LTD.; zona franca las americas; km 22-e-1; santo domingo 11606 ; DR 11606
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18333633
• Report Number: 2020394-2023-01266
• Device Sequence Number: 8451480
• Product Code: KNW
• UDI-Device Identifier: 00801741097072
• UDI-Public: (01)00801741097072
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

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 Catalogue Number: 1820MSK
• Device Lot Number: 0001461273
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 12/15/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: UNKNOWN
• Patient Sequence Number: 1
• Patient Sex: Unknown