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

Model Number 2016MSK

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/18/2023

Event Type  Injury  

Event Description

It was reported that during computed tomography guided lung biopsy procedure, the outer distal portion of the coaxial cannula broke off in the patient.It was further reported that a surgical cutdown procedure was performed to remove the broke part of the coaxial cannula.Reportedly the broken piece was removed.The current patient status was unknown.

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 provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 05/2025).

Manufacturer Narrative

H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.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 mission disposable core biopsy kit, which included the mission disposable core biopsy instrument, trocar stylet, compatible coaxial, blunt stylet and 10mm adapter for the evaluation.Upon visual evaluation, the device appeared to have residue throughout, and the device (mission needle) was received in initial configuration with cannula at 00 mm position.It appeared there was a complete circumferential break to the compatible coaxial.No other visual anomalies were noted on the returned device.Due to the nature of the complaint functional testing was not performed.Therefore, the investigation for the reported break issue is confirmed as the compatible coaxial was noted to be broken during visual evaluation.A definitive root cause for the reported break issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f ¿ the information provided 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 Description

It was reported that during computed tomography guided lung biopsy procedure, the outer distal portion of the coaxial cannula allegedly broke off in the patient.It was further reported that a surgical cutdown procedure was performed to remove the broke part of the coaxial cannula.Reportedly the broken piece was removed.The current patient status was unknown.

• Brand Name: MISSION KIT
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16361603
• MDR Text Key: 309368033
• Report Number: 2020394-2023-00063
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741097096
• UDI-Public: (01)00801741097096
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2016MSK
• Device Catalogue Number: 2016MSK
• Device Lot Number: 0001475412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Race: White