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

Catalog Number	1610MSK
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a biopsy procedure, the packaging was allegedly open without sealing.There was no patient contact.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 06/2025).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 packaging was allegedly open without any sealing.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: the physical device was not returned for evaluation.One electronic photo was provided by the customer and reviewed.Photo shows the bottom portion of the package which was noted to be in unsealed condition and the side portion were noted to be in sealed condition.Based on the photo review, the reported failure unsealed device package issue can be confirmed.Therefore the investigation is confirmed for the reported unsealed device packaging as the bottom portion of the package which was noted to be in unsealed condition.A definitive root cause for the alleged unsealed device packaging issue could not be determined based upon the provided information.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: 06/2025), g3, h6 (method).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: one unsealed mission biopsy kit was received for evaluation.During visual evaluation, the packaging was partially sealed leaving the bottom portion of the packaging unsealed, the device inside appeared to be clean and the device was returned in initial configuration with the cannula at the 00 mm position.Upon dimensional observation, both packaging length and packaging width was measured and their measurement was within the acceptable range.Due to the nature of the complaint, functional testing was not performed.One electronic photo was provided by the customer and reviewed.Photo shows the bottom portion of the package which was noted to be in unsealed condition and the side portion were noted to be in sealed condition.Based on the photo review, the reported failure unsealed device package issue can be confirmed.Therefore the investigation is confirmed for the reported unsealed device packaging as the bottom portion of the package which was noted to be in unsealed condition.A definitive root cause for the alleged unsealed device packaging issue was observed to be a 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: 06/2025), g3, h2 h11: h6 (method, 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 prior to a biopsy procedure, the packaging was allegedly open without any sealing.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 85281
• Manufacturer (Section G): CAREFUSION D.R. 203 LTD.; zona franca las americas; km 22-e-1; santo domingo 11606 ; DR 11606
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18473178
• Report Number: 2020394-2023-01375
• Device Sequence Number: 6944046
• Product Code: KNW
• UDI-Device Identifier: 00801741142567
• UDI-Public: (01)00801741142567
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/03/2024

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 Catalogue Number: 1610MSK
• Device Lot Number: 0001478981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 05/03/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 01/25/2024; 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2022
• 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