MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACLIP DT MARKER; BIOPSY INSTRUMENT

Model Number 864017D

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to the manufacturer for evaluation.The company is still investigating the issue at this time.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 864017d ultraclip dt marker allegedly had foreign material present in device.This information was received from a single source.The alleged foreign material present in device did not involve a patient as there was no patient contact.The patient age, weight, and gender were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 864017d ultraclip dt marker allegedly had foreign material present in device.This information was received from a single source.The alleged foreign material present in device did not involve a patient as there was no patient contact.The patient age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation identified foreign material within the sealed packaging.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H11: h6(results, conclusion).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.

• Brand Name: ULTRACLIP DT MARKER
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8785888
• MDR Text Key: 150867277
• Report Number: 2020394-2019-01486
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741032257
• UDI-Public: (01)00801741032257
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 864017D
• Device Catalogue Number: 864017D
• Device Lot Number: HUCY0365
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1