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

Catalog Number	ECP017G
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the encor product is adroit medical equipment.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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 an ultrasound-guided biopsy procedure, there was a piece of plastic was allegedly attached to the needle.It was further reported that the probe cover was allegedly damaged.There was no patient contact.
Event or Problem Description
It was reported prior to an ultrasound guided biopsy procedure, there was a piece of plastic was allegedly attached to the needle.It was further reported that the probe cover was allegedly damaged.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: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one encor probe complete vacuum assembly and additional components: syringe adapter received for evaluation.Upon visual evaluation the probe was received with protective tubing.The probe appeared to be clean.The probe gears appeared to be clean.It was observed that the aperture was received partially open.A sticky note was returned with the probe.The note states 'korea, pr# (b)(4) > plastic look alike particles'.The note and particles were viewed via microscopic inspection and appeared to be consistent with the material of the protective tubing.The probe and protective tubing were then viewed via microscopic inspection.The protective tubing was inspected, and no cracks were noted.The anomaly was noted to be the needle protector gate remanent area.Skiving was noted to the inner portion of the distal half of the needle protector.Material residue from the needle protector was found on the tip of the needle and within the probe aperture.No other anomalies noted.Functional testing 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.However, the investigation is unconfirmed for the reported device damaged prior to use as the needle protector was not damaged (e.G., broken or cracked).A visual anomaly was noted to the needle protector, the gate remnant area is visible on the outer side of the needle protector however the component is intact, and no cracks or breaks were noted.A definitive root cause for the reported device contamination with chemical or other material issue was determined to be manufacturing related.However, a definitive root cause for the 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.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: 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: 19371877
• Report Number: 2020394-2024-00669
• Device Sequence Number: 7619656
• Product Code: KNW
• UDI-Device Identifier: 00801741086281
• UDI-Public: (01)00801741086281(11)230920(17)250728(10)VTHVA001
• 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): 08/30/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 10/09/2024
• 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