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

Model Number	ECP0110G
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.However, photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2022).
Event or Problem Description
It was reported that during a biopsy procedure, a piece of plastic was allegedly protruding from the biopsy chamber.It was further reported that the marker could not remove from the biopsy probe and in the end.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One photo was provided for review.Photo shows the tip of the needle with blood residue.Therefore, based on the photo review, the investigation will remain inconclusive for the reported foreign material event as the device was not received and no objective evidence was provided for review.A definitive root cause for the foreign material could not be determined based upon the provided 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: 02/2022), the device was not returned.
Event or Problem Description
It was reported that during a biopsy procedure, a piece of plastic was allegedly protruding from the biopsy chamber.It was further reported that the marker could not remove from the biopsy probe and in the end.There was no reported patient injury.

• Brand Name: ENCOR BIOPSY PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12194519
• Report Number: 2020394-2021-01351
• Device Sequence Number: 3802417
• Product Code: KNW
• UDI-Device Identifier: 00801741086243
• UDI-Public: (01)00801741086243
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K040842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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: ECP0110G
• Device Catalogue Number: ECP0110G
• Device Lot Number: VTEP0137
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other