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

Catalog Number	1816MSK
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a computed tomographic guided lung biopsy procedure, the sharp inner metal stylet was allegedly detached from the plastic hub and the needle.It was further reported that a break was allegedy appeared to be where the metal stylet met the plastic hub.A coaxial was used and the procedure completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
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 (expiration date: 04/2026).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 pending return.
Additional Manufacturer Narrative
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: one trocar stylet was received without the hub.During visual evaluation, it appeared the needle was detached from the hub, the needle appeared to have residue throughout and no other anomalies were observed.Using a black light (under sandblasting process), it was noted no adhesive residue was on the trocar stylet where the hub would have been.Upon dimensional observation, the length of the returned stylet measured and the measured within specification.Therefore, the investigation is confirmed for the reported detachment of device as the returned trocar stylet was detached from its hub and the investigation is confirmed for the identified nonstandard device as a lack of adhesive residue noted on the trocar stylet.The cause for the reported detachment of device or device component and the identified nonstandard device was traced to be a manufacturing related issue.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 04/2026), g3, h6 (device).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 computed tomographic guided lung biopsy procedure, the sharp inner metal stylet was allegedly detached from the plastic hub and the needle.A coaxial was used and the procedure was completed using another device.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: 19069100
• Report Number: 2020394-2024-00471
• Device Sequence Number: 6891407
• Product Code: KNW
• UDI-Device Identifier: 00801741097065
• UDI-Public: (01)00801741097065
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: 0001516485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown