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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TI PORT W/ 6FR CHRONO CATH INTER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS TI PORT W/ 6FR CHRONO CATH INTER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Model Number 0607302
Medical Device Problem Code Component Missing (2306)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided and a lot history review was performed.The device was not returned for evaluation, therefore the investigation is inconclusive for the reported failure.The definitive root cause is unknown.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 0607302 port and catheter allegedly experienced a missing component.This information was received from one source.There was no patient involvement.Patient information was not provided.
 
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Brand Name
TI PORT W/ 6FR CHRONO CATH INTER
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 Key9208948
Report Number3006260740-2019-03142
Device Sequence Number447729
Product Code LJT
UDI-Device Identifier00801741026133
UDI-Public(01)00801741026133
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 Number0607302
Device Catalogue Number0607302
Device Lot NumberRECZ3419
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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