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

Model Number	ECP0112G
Medical Device Problem Codes	Crack (1135); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional 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.The investigation of the reported event is currently underway.(expiry date: 09/2021).
Event or Problem Description
It was reported that during a biopsy procedure, the device allegedly had a foreign material.There was no reported patient injury.
Event or Problem Description
It was reported that during a biopsy procedure, the device allegedly had a foreign material.There was no reported patient injury.
Additional 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 sealed lot sample of the encor biopsy probe was returned for evaluation.During visual evaluation, the sample packaging was opened and the probe was examined.The probe appeared clean.Foreign material was noted in the sample tissue chamber and trocar tip/aperture.A crack was noted on the distal end of the protective tubing.Skiving was noted to the inside of the protective tubing.No other anomalies were identified.Functional evaluation was not performed due to the nature of the complaint.Upon further microscopic evaluation, foreign material was noted on the tip of the aperture and aperture and flash was noted to the perimeter of the sample tray and to the port cap hole on the sample tray.Therefore, the investigation is confirmed for the reported foreign material issue in trocar tip/ aperture and in the sample tissue chamber.The investigation for the identified crack is also confirmed as the crack is visible on the distal end of the protective tubing.Additional ftir analysis has been completed on the returned material to determine the material compound identified within the sample chamber.Results indicate the material to be consistent with the tissue tray material compound, polyethylene and the material also contained small amounts of silicone.Based upon the results of the ftir analysis, it was determined the material is consistent with the sample tray material.A definitive root cause could not be determined based upon 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: 09/2021), g3, h6 (device).H11: h6 (method, result, conclusion).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.H3 other text : see h10.

• Brand Name: ENCOR BIOPSY PROBE
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12038804
• Report Number: 2020394-2021-01236
• Device Sequence Number: 3959739
• Product Code: KNW
• UDI-Device Identifier: 00801741086267
• UDI-Public: (01)00801741086267
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/09/2021

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 Model Number: ECP0112G
• Device Catalogue Number: ECP0112G
• Device Lot Number: VTDW0659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown