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

Catalog Number 1816MSK

Device Problems Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2023

Event Type  malfunction  

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: 10/2025).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.

Event Description

It was reported that prior to a biopsy procedure the holes were noted to the packaging.The procedure was completed with another device.There was no reported patient contact.

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 kit received for evaluation.Upon visual evaluation, holes were noted to the packaging.Through the sealed packaging it was noted the top housing and back housing were separated from each other.During functional testing, the packaging was opened to inspect the device.The lower cover was noted to be cracked and flattened.Damage was noted to the lower housing.The needle was not bent.Two electronic photos were provided and reviewed.The first shows a mission kit within the packaging.The label shown in the second photo was verified and matches with tw details.Therefore, based on the photo review the reported event cannot be confirmed.Therefore, the investigation is unconfirmed for the reported bent as the needle is not bent.However, the investigation is confirmed for the reported device damaged prior to use as the device was damaged within packaging and the investigation is also confirmed for the reported tear, rip or hole in device packaging is confirmed as holes were noted to the packaging.A definitive root cause for the reported needle bent, reported tear, rip or hole in device packaging reported device damaged prior to use 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: b5, d4 (expiry date: 10/2025), g3, h6 (device, method) h11: h6 (result, 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.H3 other text : see h10.

Event Description

It was reported that prior to a biopsy procedure the holes were noted to the packaging.Reportedly the needle was allegedly bent.The procedure was completed with another device.There was no reported patient contact.

• Brand Name: MISSION KIT
• Type of Device: 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 11606 ; DR 11606
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18739072
• MDR Text Key: 335755660
• Report Number: 2020394-2024-00226
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741097065
• UDI-Public: (01)00801741097065
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K171953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1816MSK
• Device Lot Number: 0001496565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1