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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TITANIUM POWERPORT W/SP, 8 FR GROSHONG, INTERMEDIATE KIT; IMPLANTABLE PORT
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BARD ACCESS SYSTEMS TITANIUM POWERPORT W/SP, 8 FR GROSHONG, INTERMEDIATE KIT; IMPLANTABLE PORT Back to Search Results
Model Number 1778000
Medical Device Problem Code Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation; therefore, the investigation is inconclusive for the foreign material as no objective evidence has been provided to confirm any alleged deficiency with the port.Based upon the available information, 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 foreign material was allegedly found in the packaging of a model 1778000 implantable port.This information was received from a single source.The alleged malfunction did not involve a patient as there was no patient contact.The patient age, weight, and gender were not provided.
 
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Brand Name
TITANIUM POWERPORT W/SP, 8 FR GROSHONG, INTERMEDIATE KIT
Common Device Name
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8800636
Report Number3006260740-2019-01996
Device Sequence Number13508239
Product Code LJT
UDI-Device Identifier00801741026874
UDI-Public(01)00801741026874
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) 07/17/2019
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 Number1778000
Device Catalogue Number1778000
Device Lot NumberRECS0999
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2019
Initial Report FDA Received Date07/17/2019
Patient Sequence Number1
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