MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTRA MARKER; BREAST TISSUE MARKER

Model Number SMMA11R

Device Problems Positioning Failure (1158); Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to bd for evaluation.Photos were returned for review.The company is still investigating the issue at this time.The device is labeled for single use.(b)(4).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model smma11r breast tissue marker allegedly experienced failure to insert / remove, failure to deploy, and device detachment.This information was received from one source.This malfunction did involve a patient with no reported patient injury.The patient was male and the age and weight were not reported.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model smma11r breast tissue marker allegedly experienced failure to insert / remove, failure to deploy, and device detachment.This information was received from one source.This malfunction did involve a patient with no reported patient injury.The patient was male and the age and weight were not reported.

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, as well as, a photo of the reported event.The investigation is confirmed for failure to deploy, difficult to remove, and detachment of device component, but is inconclusive for difficulty to insert.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.H10: g4, h6(2907- detachment of device or device component).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: SENOMARK ULTRA MARKER
• Type of Device: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9200135
• MDR Text Key: 162626735
• Report Number: 2020394-2019-04042
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741032073
• UDI-Public: (01)00801741032073
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SMMA11R
• Device Catalogue Number: SMMA11R
• Device Lot Number: VTCP00083
• Date Manufacturer Received: 03/31/2020
• Patient Sequence Number: 1