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

Catalog Number	ECP017G
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
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.However, photos were provided for review.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.
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.
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: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one encor 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.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.An anomaly was observed at the mid-section of the needle.The aperture appeared to be closed.The anomaly appears to be an indentation in the needle.The observed anomaly on the encor probe needle was further examined.The anomaly appears to be an indentation in the needle.It is unknown how or when the needle became indented.It is unknown how or when the needle became indented.A response was received from the manufacturing site, the identified indentation in the needle is a type of minor dent mark on the od surface bound to happen at tube manufacturing process which is not visible under naked eyes is acceptable.During extrusion process of tube drawing at raw tube manufacturer (k-tube technologies) there is a possibility of occurrence of this type of dent mark which is below the surface level and no opening.Based on the response from adroit, the impact or dent to the needle surface appears to be an issue at their supplier ktube technologies.Four electronic photos were provided and reviewed.The 1st and 3rd photos show one partial encor probe cannula outer od, a piece what appears to be clear material.The 2nd photos show one partial encor probe cannula outer od.A piece what appears to be clear material.The 2nd and 4th photos show one partial encor probe cannula, the cannula is closed.Therefore, based photo review and evaluation result, the investigation for the reported device contamination with chemical or other material is confirmed as residue of needle protector was observed on the distal portion of the needle.And the investigation for the identified material deformation is confirmed as minor dent mark on the od surface bound to happen at tube manufacturing process.A definitive root cause for the reported device contamination with chemical or other material issue and identified material deformation issue are 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.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: four electronic photos were provided and reviewed.The 1st and 3rd photos show one partial encor probe cannula and partial probe body.A piece what appears to be clear material is present on the trocar tip of the needle.The 2nd and 4th photos show one partial encor probe cannula and probe body; the trocar tip of the needle is not visible within the photo.A piece what appears to be clear material is present along the probe cannula.One encor 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.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.An anomaly was observed at the mid-section of the needle cannula.The aperture appeared to be closed.The anomaly appears to be an indentation in the needle cannula.Therefore, based photo review and evaluation results, the investigation is confirmed for the reported device contamination.Additionally, the investigation is confirmed for the identified material deformation (e.G., observed minor indentation on the needle cannula).Potential root causes of the reported device contamination (plastic on the needle) are, but not limited to, tolerance stack-up between the needle trocar tip and plastic tip protector and user error (e.G., bend needle protector, repeated removal and replacement of tip protector).The customer reported, removing the probe cover before the procedure started and noted the plastic on the needle.It is unknown if the placement of the plastic tip protector during final assembly at manufacturing or the removal of the tip protector by the customer contributed to this event.It is likely the needle was placed in the tip protector at an angle and therefore, determined to be manufacturing related.The definitive root cause for the identified material deformation (e.G., minor indentation of the needle cannula) 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 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.

• 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: 19229714
• Report Number: 2020394-2024-00585
• Device Sequence Number: 12445713
• Product Code: KNW
• UDI-Device Identifier: 00801741086281
• UDI-Public: (01)00801741086281(11)230912(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,Followup
• Report Date (Section B): 05/28/2025

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: 09/04/2024; 05/28/2025
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 09/22/2024; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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