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

Model Number	1816MSK
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A voluntary recall has been initiated for mission disposable core biopsy instrument kit which are product catalog/lot number specific.Reportedly the mission disposable core biopsy instrument kit may have a mismatch between the coaxial and the needle in the kit devices.Device incompatibility due to the external diameter of the biopsy instrument being larger than the internal diameter of the coaxial needle is most likely to result in no patient involvement or a clinically insignificant procedural delay.If the coaxial needle has been deployed, an additional device would be required.If a compatible device is not immediately available, the procedure may need to be repeated, resulting in minor injury from a new needle puncture and care may be prolonged.If efforts are made to use the device despite incompatibility, unusual adverse events such as needle tip breakage may occur.To date there have been no adverse events worldwide reported related to this issue.As result of the field action, this event is being reported as a malfunction reportable event.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 not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2025).
Event or Problem Description
It was reported that during biopsy procedure, the device was allegedly had incompatible issue.The procedure was completed by using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a biopsy procedure, the device allegedly had incompatible issue.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: a voluntary recall has been initiated for mission disposable core biopsy instrument kit which are product catalog/lot number specific.Reportedly the mission disposable core biopsy instrument kit may have a mismatch between the coaxial and the needle in the kit devices.Device incompatibility due to the external diameter of the biopsy instrument being larger than the internal diameter of the coaxial needle is most likely to result in no patient involvement or a clinically insignificant procedural delay.If the coaxial needle has been deployed, an additional device would be required.If a compatible device is not immediately available, the procedure may need to be repeated, resulting in minor injury from a new needle puncture and care may be prolonged.If efforts are made to use the device despite incompatibility, unusual adverse events such as needle tip breakage may occur.To date there have been no adverse events worldwide reported related to this issue.As result of the field action, this event is being reported as a malfunction reportable event.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: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.Two electronic photos were provided and reviewed.The first photo shows the product labelling information which matches with the trackwise details.The second photo shows that the three coaxial needles are placed inside a sealed package.Based on the photo review, the reported device-device incompatibility issue cannot be confirmed.Therefore, the investigation is inconclusive for the reported device-device incompatibility as no objective evidence was provided for the review.A definitive root cause for the alleged device-device incompatibility 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.H10: d4 (expiry date: 01/2025), g3, h6 (method) h11: e1, h6 (result, conclusion) 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 : device not returned.

• Brand Name: MISSION KIT
• Common Device Name: 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: 16626699
• Report Number: 2020394-2023-00206
• Device Sequence Number: 4457814
• Product Code: KNW
• UDI-Device Identifier: 00801741097065
• UDI-Public: (01)00801741097065
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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 Model Number: 1816MSK
• Device Catalogue Number: 1816MSK
• Device Lot Number: 0001454295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: UNKNOWN
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male