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

Catalog Number ECP017G

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It was reported that prior to a biopsy procedure, the probe needle allegedly had red paints on them.It was further reported that the user guess that the red paints are from the red pointer.There was no patient contact.

Manufacturer Narrative

H10: 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.H10: d4 (expiration date: 02/2024).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.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and did not indicate a manufacturing related cause for this event.Investigation summary: one encor probe, removable probe cover, complete vacuum assembly with additional sample tray and syringe adapter were received for evaluation.During visual evaluation, it was observed that the aperture of the probe was received partially open.On further observation, a red unknown material was noted to be on the cannula.No other visual anomalies were noted to the device.The functional testing was not performed, due to the nature of the complaint.Also, one electronic photo was provided and reviewed in that photo, a red unknown paint like substance were noted on the encor probe's needle.Based on both the provided photo and the returned sample analysis, the investigation for the reported device contamination with chemical or other material issue can be confirmed as the probe was received with a red unknown material on the cannula.A definitive root cause for the reported device contamination with chemical or other material issue was noted to be a manufacturing related issue.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: 02/2024), g3 h11: h6 (method, result, conclusion) 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 : see h10.

Event Description

It was reported that prior to a biopsy procedure, the probe needle allegedly had red paints on it.It was further reported that the red paints are from the red pointer.There was no patient contact.

• Brand Name: ENCOR BIO PROBE 7G
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18172671
• MDR Text Key: 328643627
• Report Number: 2020394-2023-01077
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741086281
• UDI-Public: (01)00801741086281
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K051158
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECP017G
• Device Lot Number: VTGP0086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• 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