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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CV SLIM SPNB 6 FR CHRONOFLEX SLTH; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS POWERPORT CV SLIM SPNB 6 FR CHRONOFLEX SLTH; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Model Number 5676300
Medical Device Problem Codes Component Incompatible (1108); Component Missing (2306)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the device was returned and a lot history review was performed.The device was returned for evaluation and missing component was confirmed.The cause of this is manufacturing related.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 5676300 port and catheter allegedly experienced incompatible component and missing components.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.
 
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Brand Name
POWERPORT CV SLIM SPNB 6 FR CHRONOFLEX SLTH
Common Device Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9211268
Report Number3006260740-2019-03203
Device Sequence Number3146641
Product Code LJT
UDI-Device Identifier00801741110771
UDI-Public(01)00801741110771
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/18/2019
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
Operator of Device No Information
Device Model Number5676300
Device Catalogue Number5676300
Device Lot NumberRECX3530
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2019
Initial Report FDA Received Date10/18/2019
Patient Sequence Number1
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