MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIO PROBE 10G; BIOPSY INSTRUMENT

Model Number ECP0110G

Device Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation as well as photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2023).

Event Description

It was reported that prior to breast biopsy procedure, the device allegedly had black viscous substance on the needle tip.The procedure was completed by using another device.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one encor biopsy probe was returned for evaluation.Upon visual evaluation, the probe appeared clean and the sample was inadvertently placed in cidex, however a jelly-like substance was noted on the surface of the cutter.Upon microscopic visual observation, viscous substance was noted on the outside of the cutter.One electronic photo was provided and reviewed.The photo shows the needle part of the encor probe and viscous substance is present in the outer part of the cutter.Therefore, based on the photo review and sample evaluation, the reported device contamination with chemical or other material is confirmed as viscous substance is present in the outer part of the cutter.However, the reported material fragmentation is inconclusive as no evidence of the black substance was found on the device.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 01/2023).H11: section a through f ¿ the information provide 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 a breast biopsy procedure, the device allegedly had black viscous substance on the needle tip.The procedure was completed using another device.There was no patient contact.

• Brand Name: ENCOR BIO PROBE 10G
• Type of Device: 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12825210
• MDR Text Key: 280875433
• Report Number: 2020394-2021-01961
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741086243
• UDI-Public: (01)00801741086243
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ECP0110G
• Device Catalogue Number: ECP0110G
• Device Lot Number: VTFN0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2021
• 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
• Patient Sex: Female