MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIO PROBE 7G; BIOPSY INSTRUMENT

Catalog Number	ECP017G
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	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of an ultrasound-guided breast biopsy procedure, a piece of plastic was allegedly found attached to the surface of the needle.The procedure was completed by using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the encor product is adroit medical equipment.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 07/2025) 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.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one encor probe was received for evaluation.Upon visual evaluation, the device was received with protective tubing seated on the probe needle.Thorough examination of the needle protector showed skiving throughout.The needle protector was carefully removed for further examination of the needle.Residue of needle protector was observed on the distal portion of the needle.Dried blood on the tip of the needle was observed.The aperture appeared to be closed.Functional testing was not required due to the nature of the reported event.Therefore, the investigation is confirmed for the reported device contamination with chemical or other material issue as the material residue from the needle protector was found on the tip of the needle.A definitive root cause for the reported device contamination with chemical or other material issue was 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: 07/2025.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 or Problem Description
It was reported that during an ultrasound guided breast biopsy procedure, the piece of plastic was allegedly found to be attached to the needle.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ENCOR BIO PROBE 7G
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19236831
• Report Number: 2020394-2024-00589
• Device Sequence Number: 8106635
• Product Code: KNW
• UDI-Device Identifier: 00801741086281
• UDI-Public: (01)00801741086281
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K051158
• 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
• Report Date (Section B): 08/29/2024

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 Expiration Date: 07/28/2025
• Device Catalogue Number: ECP017G
• Device Lot Number: VTHVA001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 09/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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