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

Model Number	1810MSK
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for a biopsy procedure, the package was allegedly found unsealed.There was no patient contact.
Additional Manufacturer Narrative
H10: 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.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2025).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 the preparation for a biopsy procedure, the package was allegedly found to be opened.There was no patient contact.
Additional Manufacturer Narrative
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: received one mission disposable core biopsy instrument, trocar stylet, compatible coaxial, blunt stylet, 10mm adapter and depth stop for the evaluation.Upon visual evaluation, the device was appeared to be clean and the device was returned in initial configuration.It was noted that all components were returned.Further, it was noted that no seal was noted to the bottom of the packaging.Upon dimensional observation, the length of the packaging pouch was measured and measurement was within the acceptable range.Two electronic photos were provided and it were reviewed.The first photo shows the bottom portion of the package which was noted to be in unsealed condition and the side portions were noted to be in sealed condition.The second photo also shows the same bottom portion of package, noted to be unsealed condition but in a different angle.Based on the photo review, the reported failure unsealed device package issue can be confirmed.Therefore, based on both the photo review and the return sample evaluation result - the whole investigation is determined to be confirmed for the reported unsealed device packaging issue as no seal was noted to the bottom of the packaging.A definitive root cause for the alleged unsealed device packaging 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.D4 (expiration date: 08/2025).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.
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: received one mission disposable core biopsy instrument, trocar stylet, compatible coaxial, blunt stylet, 10mm adapter and depth stop for the evaluation.Upon visual evaluation, the device was appeared to be clean and the device was returned in initial configuration.It was noted that all components were returned.Further, it was noted that no seal was noted to the bottom of the packaging.Upon dimensional observation, the length of the packaging pouch was measured and measurement was within the acceptable range.Two electronic photos were provided and it were reviewed.The first photo shows the bottom portion of the package which was noted to be in unsealed condition and the side portions were noted to be in sealed condition.The second photo also shows the same bottom portion of package, noted to be unsealed condition but in a different angle.Based on the photo review, the reported failure unsealed device package issue can be confirmed.Therefore, based on both the photo review and the return sample evaluation result - the whole investigation is determined to be confirmed for the reported unsealed device packaging issue as no seal was noted to the bottom of the packaging.A definitive root cause for the alleged unsealed device packaging issue is determined to be manufacturing related.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 08/2025).H11: h6 (conclusion).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 or Problem Description
It was reported that during the preparation for a biopsy procedure, the package was allegedly found to be opened.There was no patient contact.

• 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): CAREFUSION D.R. 203 LTD.; zona franca las americas; km 22-e-1; santo domingo PR 11606 ; DR 11606
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17097077
• Report Number: 2020394-2023-00408
• Device Sequence Number: 11239625
• 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): 05/14/2024

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: 0001488975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 05/14/2024
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 09/13/2023; 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown