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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GEL MARK ULTRA MARKER

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BARD PERIPHERAL VASCULAR, INC. GEL MARK ULTRA MARKER Back to Search Results
Catalog Number GMUEC10GSS
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that two weeks after the breast tissue marker was placed, one of the gel pellets came out of the access site.No additional treatment was provided.No patient injury was reported.
 
Manufacturer Narrative
After further clinical review of this event with bard's medical department, this event was reassessed and determined to be mdr reportable as a malfunction pursuant to 21 cfr part 803.A manufacturing review could not be performed, as the lot number was not provided.The investigation is inconclusive, as the sample was not returned for evaluation.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.The current gel mark ultra breast biopsy marker instructions for use (ifus) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.Despite good faith efforts to obtain additional information, the complainant/report was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
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Brand Name
GEL MARK ULTRA MARKER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
tempe AZ
Manufacturer (Section G)
INFUS MEDICAL (THAILAND)
706 moo 4, bangpoo industrial estate
samutprakarn province 1028 0
TH   10280
Manufacturer Contact
linda morocho
1625 west 3rd st.
tempe, AZ 85281
4808949515
MDR Report Key4909731
MDR Text Key6833985
Report Number2020394-2015-00948
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/08/2015
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 Catalogue NumberGMUEC10GSS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/10/2015
Initial Date FDA Received06/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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