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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. SENOMARK MARKER BREAST TISSUE MARKER Back to Search Results
Model Number SMTEC10G
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided for the reported malfunction, therefore a lot history review was performed. The device was not returned for evaluation. Based on the photo review, the investigation is confirmed for reported package damage. Based upon the available information, the definitive root cause for this event is unknown. The device is labeled for single use.
 
Event Description
This report summarizes one malfunction. A review of the malfunction indicated that model smtec10g breast tissue marker allegedly experienced a tear in the package. This report was received from one source. This malfunction did not involve a patient as there was no patient contact. The patient's age, weight, and gender were not provided.
 
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Brand NameSENOMARK MARKER
Type of DeviceBREAST TISSUE MARKER
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
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10282895
MDR Text Key199084846
Report Number2020394-2020-04496
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 07/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSMTEC10G
Device Catalogue NumberSMTEC10G
Device Lot NumberVTDR00202
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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