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

Catalog Number	1410MS
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/26/2025
Type of Reportable Event	Serious 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.H11: section a through f ¿ the information provide 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
On (b)(6) 2025, a two-year-old patient underwent an ultrasound guided liver biopsy through hard density tissue using mission disposable biopsy needle, the device allegedly failed to obtain sample.It was further reported that post puncture, the patient allegedly experienced hemorrhage and subsequent hemorrhagic shock and hemoperitoneum requiring surgical intervention with exploratory laparotomy to control bleeding.No coaxial was used.Current status of the patient is unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one mission device was received for evaluation.Upon visual evaluation, the device appeared to be clean and received with protective tubing.The device was returned in initial configuration.During functional testing, the device was fully primed without issue.The device was then inserted into a chicken breast without issue.The device was further tested by cocking and firing the device 10 times into chicken breast at each penetration depth, for a total of 20 tests.The device was able to prime, advance and fire properly.All 20 samples were obtained without issue.Therefore, the investigation is unconfirmed for the reported failure to obtain sample as the device was able to prime, fire and able to obtain all 20 samples with no issues.A definitive root cause for the failure to obtain sample could not be determined based upon the provided information.It is unknown whether patient and/or procedural issues contributed to the reported event.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (component, method, result, conclusion).Section a through f ¿ the information provide 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
On (b)(6) 2025, a patient underwent an ultrasound guided liver biopsy through hard density tissue using mission disposable biopsy needle, the device allegedly failed to obtain sample.It was further reported that post puncture, the patient allegedly experienced hemorrhage and subsequent hemorrhagic shock and hemoperitoneum requiring surgical intervention with exploratory laparotomy to control bleeding.No coaxial was used.Current status of the patient was unknown.

• Brand Name: MISSION NEEDLE
• 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: 21958545
• Report Number: 2020394-2025-00655
• Device Sequence Number: 9274661
• Product Code: KNW
• UDI-Device Identifier: 00801741096945
• UDI-Public: (01)00801741096945(17)270728(10)0001581117
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K171953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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 Catalogue Number: 1410MS
• Device Lot Number: 0001581117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown