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

Model Number	1810MSK
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only one device was involved in this reportable event at the user facility.However, the user identified an additional four unused lot samples from the same lot/product catalog number with this same issue.Two of the unused lot samples were returned for evaluation as part of the investigation.The investigation is currently ongoing.Due to system limitations, the manufacturing location has been entered as unknown; however, the correct manufacturing location is bd (b)(6).
Event or Problem Description
It was reported that during a biopsy procedure, the device needle was allegedly blunt.It was further reported that the needle was allegedly longer than the actual needle.There was no reported patient injury.
Additional Manufacturer Narrative
H10: only one device was involved in this reportable event at the user facility.However, the user identified an additional four unused lot samples from the same lot/product catalog number with this same issue.Two of the unused lot samples were returned for evaluation as part of the investigation.H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for this 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: two mission disposable core biopsy kit/instruments were retuned for evaluation and one photo was provided for review.During visual evaluation, sample 1 was opened and appeared to be clean, sample 2 was a sealed lot sample and therefore appeared to be clean.Further it was noted that the blunt stylet was longer length than the compatible coaxial on both devices.Functional testing was not conducted due to the nature of the complaint.One electronic photo was provided and reviewed.The provided photo shows the mission kit (cannula, biopsy needle and blunt tip stylet).Provided photo shows the longer length blunt tip stylet.Therefore, based on the photo review and sample evaluation, the investigation is confirmed for the reported incorrect length blunt tip stylet issue.An external investigation concluded that the root cause is manufacturing related, as the correct length blunt tip stylet was not included in the packaging at the time of manufacture, most likely as a result of a manufacturing line clearance issue.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date:06/2023), g3 h11: h6 (result and conclusion) 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.See h10.
Event or Problem Description
It was reported that during a biopsy procedure, the device needle was allegedly blunt.It was further reported that the needle was allegedly longer than the actual needle.There was no reported patient injury.

• Brand Name: MISSION BIOPSY KIT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11638281
• Report Number: 2020394-2021-00827
• Device Sequence Number: 11604861
• Product Code: KNW
• UDI-Device Identifier: 00801741097058
• UDI-Public: (01)00801741097058
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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 Expiration Date: 06/28/2023
• Device Model Number: 1810MSK
• Device Catalogue Number: 1810MSK
• Device Lot Number: 0001369150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 03/27/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other