MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTBREAST TISSUE MARKER; BIOPSY INSTRUMENT

Model Number SMAT9C

Device Problems Image Display Error/Artifact (1304); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2024).Device not returned.

Event Description

It was reported that post breast marker placement procedure, the device allegedly had an image display error.There was no reported patient injury.

Manufacturer Narrative

H10: the initial mdr was inadvertently submitted with a g3 date of 08/20/2021.The correct g3 date is 08/19/2021.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: the physical device was not returned for evaluation.Two medical image(s) were provided and reviewed.Dense breast tissue is present.There is a breast biopsy ¿coil¿ clip present on one of the images that is assumed to be post biopsy, and it can not be excluded that it was present on the prior.It is not know what ¿foreign material¿ they are talking about.Assuming it is a before and after sequence, and seen a coil placed.There are dense calcifications on both images that are only more apparent on the magnification view with the coil.It would be easier to tell that the calcifications were present before hand if the before study had been magnified.Based on the image review, the reported foreign material is inconclusive as the images are not magnified.Therefore the investigation is inconclusive for the reported foreign material.A definitive root cause for the alleged foreign material 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: 01/2024), g3, h6 (method).H11: b3, b5, h6 (device, result, 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.H3 other text : device not returned.

Event Description

It was reported that post breast marker placement procedure, the device allegedly had foreign material.There was no reported patient injury.

• Brand Name: SENOMARK ULTBREAST TISSUE MARKER
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12479013
• MDR Text Key: 271656847
• Report Number: 2020394-2021-01691
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741032080
• UDI-Public: (01)00801741032080
• Combination Product (y/n): N
• PMA/PMN Number: K123911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2021

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
• Device Operator: Health Professional
• Device Model Number: SMAT9C
• Device Catalogue Number: SMAT9C
• Device Lot Number: VTFN00058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1