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

Catalog Number	ECP017G
Medical Device Problem Codes	Dull, Blunt (2407); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.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 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 : device pending return.
Event or Problem Description
It was reported that prior to a breast biopsy procedure, the foreign particle was allegedly found in the tip of the needle.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.Investigation summary: one encor biopsy probe, probe cover, an additional sealed saline syringe and complete sample trap assembly were received for evaluation.During visual evaluation, the device was received with protective tubing seated on the probe needle and the sample appeared to be clean, no blood residue was found.Skiving was noted throughout the inner side of the needle protector length.The needle protector remanent were observed on the distal portion of the needle and the needle distal tip was noted to be bent (dull).Due to the nature of the complaint, functional testing was not performed.Two electronic photos were provided and reviewed.The first and second photos show one partial encor probe cannula, the cannula is closed.A piece what appears to be clear material along with blood residue was noted to the distal portion of the needle.Therefore, based on the photo review and sample evaluation results, the investigation is confirmed for the reported device contamination with chemical or other material as the skiving was noted throughout the inner side of the needle protector length and needle protector remanent were observed on the distal portion of the needle.And the investigation is confirmed for the identified dull needle as the needle distal tip was noted to be bent.A definitive root cause for the identified dull needle issue could not be determined based upon the provided information.And the definitive root cause for the reported device contamination 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.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 a breast biopsy procedure, the foreign particle was allegedly found in the tip of the needle.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): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19123153
• Report Number: 2020394-2024-00524
• Device Sequence Number: 7722492
• 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): 08/29/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 09/17/2024
• 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