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	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number of the device was provided.The device history records are currently under review.The device is expected to be returned for evaluation.The investigation is currently underway.Due to system limitations, the manufacturing location has been entered as unknown; however, the correct manufacturing location is bd (b)(4).
Event or Problem Description
It was reported that prior to a biopsy procedure, the package came with a blunt tip stylet that was much longer than the introducer and needle.There was no patient contact.
Additional Manufacturer Narrative
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: the physical device was not returned for evaluation.Three electronic photos were provided for review.First photo shows the device within the sealed packaging, from the provided photo incorrect length blunt tip stylet was noted in the tip.Second photo shows the devices within the sealed packaging.Third photo shows the label of the product.Therefore, 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).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.
Event or Problem Description
It was reported that prior to a biopsy procedure, the package came with a blunt tip stylet that was much longer than the introducer and needle.There was no patient contact.

• 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: 11637878
• Report Number: 2020394-2021-00826
• Device Sequence Number: 14252207
• Product Code: KNW
• UDI-Device Identifier: 00801741097058
• UDI-Public: (01)00801741097058
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/24/2021

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?: No
• Initial Date Received by Manufacturer: 03/27/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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