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

Catalog Number	1816MSK
Medical Device Problem Codes	Device-Device Incompatibility (2919); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
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 is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 11/2025).H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during a biopsy procedure, the external diameter of the biopsy instrument being larger than the internal diameter of the coaxial needle.There was no reported patient injury.
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: 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: the physical sample was returned for evaluation.During visual evaluation, the device appeared to have residue throughout and the sample was returned in initial configuration with the cannula at the 00mm position.There were no visual anomalies noted on the device.Upon functional testing, an attempt was made to insert the mission needles into the compatible coaxial, but it was unsuccessful.Upon dimensional testing - the outer diameter of the mission instrument and the inner diameter of the compatible coaxial measurements were measured.It was noted that, the outer diameter of the mission instrument measurement was within the acceptable range but the inner diameter of the compatible coaxial measurement was not within acceptable range.Therefore, the investigation is confirmed for the identified component misassembled as the received sample had incorrectly sized coaxial needle.Also, the investigation is confirmed for the reported device-device incompatibility as the mission device did not fit into the compatible coaxial.A definitive root cause for the alleged device-device incompatibility and identified component misassembled issue could be determined as the manufacturing issue.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 11/2025), g3, h6 (device) h11: h6 (method, result, conclusion) h11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during a biopsy procedure, the external diameter of the biopsy instrument being larger than the internal diameter of the coaxial needle.There was no reported patient injury.

• Brand Name: MISSION KIT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 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: 18524112
• Report Number: 2020394-2023-01399
• Device Sequence Number: 7875771
• Product Code: KNW
• UDI-Device Identifier: 00801741097065
• UDI-Public: (01)00801741097065
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: 1816MSK
• Device Lot Number: 0001500891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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