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

Model Number 1816MSK

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 01/05/2023

Event Type  malfunction  

Event Description

It was reported that during a biopsy procedure, the needle was allegedly bent upon insertion into site of biopsy.It was further reported that the needle was almost broke inside the patient.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, a photo and an image were provided for review.The investigation of the reported event is currently underway.

Manufacturer Narrative

H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.Device not returned.

Event Description

It was reported that during a computed tomography biopsy procedure, the needle was allegedly bent upon insertion into the site of biopsy.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: MISSION KIT
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16282792
• MDR Text Key: 309082968
• Report Number: 2020394-2023-00025
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1816MSK
• Device Catalogue Number: 1816MSK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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