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

Model Number DS4001

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  malfunction  

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 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.

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 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
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12342776
• MDR Text Key: 267281022
• Report Number: 2020394-2021-01485
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741086090
• UDI-Public: (01)00801741086090
• Combination Product (y/n): N
• PMA/PMN Number: K111100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR