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 review of the device history records 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: 01/2022).
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 enspire vacuum and rinse tubing cassette was returned for evaluation.Sample was a sealed lot sample.Hence the sample was clean and not used.There was no evidence of breach to the packaging, the female connector to the vaccuum tubing was inspected and it was noted it was cloudy as well.An in-house cassette was opened for reference and this sample was not cloudy.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 for the reported failure 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: 01/2022).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.
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.

• 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: 12342776
• Report Number: 2020394-2021-01485
• Device Sequence Number: 3901611
• 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): 08/27/2021

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: 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: 07/26/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR