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

Model Number	1810MSK
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 09/2022).
Event or Problem Description
It was reported that during a biopsy procedure, the device allegedly found foreign material.The procedure was completed by using another device.There was no reported patient contact.
Additional Manufacturer Narrative
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: one mission disposable core biopsy kit was returned for evaluation.During visual evaluation the biopsy instrument appeared to be bloody and was received with protective tubing.Foreign material appeared to be taped to part of the clear plastic packaging.Therefore, the investigation is inconclusive for the reported foreign material issue as device was returned in open condition.A definitive root cause for the reported foreign material could not be determined based upon the provided information.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: 09/2022), g3.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.
Event or Problem Description
It was reported that during a biopsy procedure, foreign material was allegedly found on the device.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
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: one mission disposable core biopsy kit was returned for evaluation.During visual evaluation the biopsy instrument appeared to be bloody and was received with protective tubing.Foreign material appeared to be taped to part of the clear plastic packaging.Therefore, the investigation is inconclusive for the reported foreign material issue as device was returned in open condition.A definitive root cause for the reported foreign material could not be determined based upon the provided information.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: 09/2022).
Event or Problem Description
It was reported that prior to a biopsy procedure, foreign material was allegedly found on the device.The procedure was completed using another device.There was no patient contact.

• Brand Name: BIOPSY MISSION KIT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11567014
• Report Number: 2020394-2021-00679
• Device Sequence Number: 11643019
• Product Code: KNW
• UDI-Device Identifier: 00801741097058
• UDI-Public: (01)00801741097058
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2023

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: 1810MSK
• Device Catalogue Number: 1810MSK
• Device Lot Number: HUDW2484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 07/02/2021; 02/10/2023
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 07/12/2021; 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown