MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ELEVATION PROBE; DISPOSABLE BIOPSY

Model Number	EV10
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	10/31/2022
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, photos were provided for review.The investigation of the reported event is currently underway.Expiration date: 01/2023.
Event or Problem Description
It was reported that upon opening the device, a foreign material was allegedly observed in the package.There was no patient contact.
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 elevation breast biopsy probe was returned for evaluation.On visual evaluation, the device appeared to be clean and the sample tank basket was returned.And the device was carefully inspected throughout as well as packaging and no foreign material was spotted.Therefore, the investigation for the reported foreign material is unconfirmed as the foreign material was not noted on the device.Two electronic photos were provided for review.First photo shows the package where the blood residue like material is noted on the device package.Second photo shows the device where the blood residue was noted on the body of the device.Therefore, based on the photo review, the reported failure foreign material could not be confirmed.Therefore, the investigation for the reported foreign material is kept as inconclusive.A definitive root cause for the alleged 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 (expiration date: 01/2023), g3.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 or Problem Description
It was reported that upon opening the device, a foreign material was allegedly observed in the package.There was no patient contact.

• Brand Name: ELEVATION PROBE
• Common Device Name: DISPOSABLE BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FERROSAN MEDICAL DEVICES SP. Z.O.O.; ul. koksowa 3; 70-031 szczecin ; PL
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15866803
• Report Number: 2020394-2022-00935
• Device Sequence Number: 5361966
• Product Code: KNW
• UDI-Device Identifier: 00801741182372
• UDI-Public: (01)00801741182372
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192948
• 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): 01/25/2023

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: EV10
• Device Catalogue Number: EV10
• Device Lot Number: 91014808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 11/26/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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