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

Model Number	DS4001
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	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s), and provides general instructions for use, as well as warnings, precautions, and potential complications associated with the device.Upon receipt of new, or additional information, a follow-up report will be submitted as applicable.Expiry date (01/2022); device not returned.
Event or Problem Description
It was reported that during a preparation for biopsy, white powder was allegedly found at the connection part of suction rinse tube cassette.There was no reported patient contact.
Event or Problem Description
It was reported that during a preparation for biopsy, white powder was allegedly found at the connection part of suction rinse tube cassette.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 encor enspire vacuum and rinse tubing cassettes were returned for evaluation.The sample appeared to be clean and not used.It was noted the female connector to the vaccuum tubing had white dry residue.The residue could be scratched off and appeared to be present on the exterior and not the interior of the connector.Additional ftir analysis was performed and determined the white residue material content is excess adhesive (glue), a known component used during the manufacture of this device.Therefore, the investigation is confirmed for the reported foreign material issue as the white residue was found to be excess adhesive (glue).A definitive root cause could not be determined based upon the available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 01/2022), g3.H11: h6 (method, result).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.H3 other text : see h10.

• Brand Name: ENCOR ENSPIRE CASSETTE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10883276
• Report Number: 2020394-2020-20553
• Device Sequence Number: 11514899
• Product Code: KNW
• UDI-Device Identifier: 00801741086090
• UDI-Public: (01)00801741086090
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111100
• 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): 12/16/2020

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: DS4001
• Device Catalogue Number: DS4001
• Device Lot Number: VTDN0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 08/04/2021
• 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
• Patient Age: 50 YR