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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTBREAST TISSUE MARKER; BIOPSY INSTRUMENT Back to Search Results
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.
 
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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 Key12479013
MDR Text Key271656847
Report Number2020394-2021-01691
Device Sequence Number1
Product Code NEU
UDI-Device Identifier00801741032080
UDI-Public(01)00801741032080
Combination Product (y/n)N
PMA/PMN Number
K123911
Number of Events Reported1
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 NumberSMAT9C
Device Catalogue NumberSMAT9C
Device Lot NumberVTFN00058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/20/2021
Initial Date FDA Received09/16/2021
Supplement Dates Manufacturer Received12/10/2021
Supplement Dates FDA Received12/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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