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

Catalog Number	1810MSK
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
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 device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that prior to a biopsy procedure, the seal was allegedly open at the one side/ bottom side of needle pack.There was no patient contact.
Event or Problem Description
It was reported that prior to a biopsy procedure, the seal was allegedly open at the one side/ bottom side of needle pack.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one unsealed mission biopsy device was received for evaluation.During visual evaluation, the mission pouch was noted to be unsealed on the bottom seal; no evidence of a seal was noted.Upon dimensional observation, the length of the mission pouch was measured and noted to be functional testing was not performed due to the nature of the complaint.Two electronic photos were provided, and it was reviewed.The first photo shows the bottom side of the package which was noted to be in an opened condition.The second photo shows the labelling information which verifies/matches with the tw details.Based on the provided photos, the reported unsealed device packaging cannot be confirmed.Therefore, the investigation is confirmed for the reported unsealed device packaging as the returned mission pouch was noted to be unsealed.A definitive root cause for the alleged unsealed device packaging issue was observed to be a manufacturing related.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier (udi) #), g1, 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.

• Brand Name: BIOPSY 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 PR 11606 ; DR 11606
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21025794
• Report Number: 2020394-2024-01912
• Device Sequence Number: 8342469
• Product Code: KNW
• UDI-Device Identifier: 00801741097058
• UDI-Public: (01)00801741097058(11)240504(17)270328(10)0001563522
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 1810MSK
• Device Lot Number: 0001563522
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2024
• 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