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

Catalog Number	1816MSK
Medical Device Problem Codes	Device-Device Incompatibility (2919); Component Misassembled (4004)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ct-guided lung biopsy procedure, the needle was unable to advance through the coaxial.The device and needle were removed and a second attempt to obtain the biopsy was done with a new device of a different lot number.During the placement of the second needle, the patient allegedly experienced a pneumothorax.No chest tube was placed at that time the physician was able to resolve the pneumothorax.A coaxial needle was used during the procedure.The procedure was successfully completed using another device.The device was returned for analysis.
Additional Manufacturer Narrative
H10: the device history records have been reviewed and this lot met all release criteria.One mission disposable core biopsy instrument was returned for evaluation.On visual evaluation, it was noted that the components received were one disposable mission biopsy instrument, one blunt stylet and compatible coaxial needle loaded to a trocar stylet.It was noted that there was residue on the compatible coaxial.Furthermore, it was noted that the device was returned in primed configuration at the 10mm position.An attempt to insert the biopsy instrument through the coaxial was performed.The biopsy instrument was unable to go through the coaxial.Dimensional analysis of the outer diameter (od) for the biopsy instrument was performed and found to be within specification.Dimensional analysis of the inner diameter (id) for the coaxial was taken and found to be out of specification.The id of the returned coaxial is consistent with a 19ga coaxial instead of the required 17ga coaxial.Therefore, the investigation is confirmed for component misassembled and the reported device-device incompatibility.A definitive root cause for the alleged device-device incompatibility and the identified component misassembled is manufacturing related.An internal investigation was initiated to address incorrected components with mission kits.Medwatch mfg.Report number 2020394-2023-00639 was received for this event.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 NEEDLE
• 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: 18793772
• Report Number: 2020394-2024-00281
• Device Sequence Number: 7331188
• Product Code: KNW
• UDI-Device Identifier: 00801741097065
• UDI-Public: (01)00801741097065
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2025
• Device Catalogue Number: 1816MSK
• Device Lot Number: 0001500891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown