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

Catalog Number MC1410

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/01/2023

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, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 07/2026).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 an ultrasound-guided biopsy procedure, a plastic microfiber was allegedly found attached to the handle and extended along the needle shaft several inches, on the device.The procedure was completed using another device.There was no patient contact.

Event Description

It was reported that prior to an ultrasound-guided biopsy procedure, a plastic microfiber was allegedly found attached to the handle and extended along the needle shaft several inches, on the device.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: received one maxcore disposable core biopsy instrument for evaluation.During visual evaluation, the device appeared to be clean, and the device was returned fully primed, with the top and bottom slide pulled back.It was noted that there was a white fiber material around the retainer of the device.During microscopic evaluation, the white material appeared to be fibrous and thin.One electronic photo was provided, and it was reviewed.The provided photo shows a foreign material like substance was observed close to the needle.Based on the photo review, the reported failure can be confirmed.Based on both the provided photo and the returned sample analysis, the investigation is confirmed for the reported device contamination with chemical or other material issue as a white fiber material was noted with the device.A definitive root cause for the reported device contamination was noted to be a manufacturing related issue.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: 07/2026).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.

• Brand Name: MAXCORE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18208134
• MDR Text Key: 328967871
• Report Number: 2020394-2023-01098
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741084423
• UDI-Public: (01)00801741084423
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC1410
• Device Lot Number: REHV0774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2023
• 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