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

Catalog Number 1810MS

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: received one unsealed mission disposable core biopsy instrument for evaluation.Upon visual evaluation the device was returned in primed configuration with the cannula at the 10 mm position.It was noted that the spring to the plunger was visible.No other visual anomalies were noted to the device.The functional testing was not performed, due to the condition the sample was received.Also, one electronic photo was reviewed.The photo shows the label information which verifies and matches with trackwise and it shows that the spring to the plunger was visible in mission biopsy device.Therefore, based on the photo review, the reported failure detachment can be confirmed.Therefore, the investigation is confirmed for the reported detachment of device or device component as it was noted the spring to the plunger was visible on the device.A definitive root cause for the alleged detachment of device or device component could not be determined based upon the provided information.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: 08/2024).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.H3 other text : see h10.

Event Description

It was reported that during a biopsy procedure, the device spring allegedly came out while priming.The procedure was completed with another device.There was no reported patient injury.

• Brand Name: MISSION NEEDLE
• Type of Device: 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: 17947682
• MDR Text Key: 325809404
• Report Number: 2020394-2023-00870
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741096983
• UDI-Public: (01)00801741096983
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K171953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1810MS
• Device Lot Number: 0001431572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1