POWERPORT MRI ISP ALTERNATIVE BUMPLS, 8F CHRONOFLEX, W SP 4808060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-19 for POWERPORT MRI ISP ALTERNATIVE BUMPLS, 8F CHRONOFLEX, W SP 4808060 manufactured by Bard Access Systems.

Event Text Entries

[184754654] As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Patient Sequence No: 1, Text Type: N, H10


[184754655] It was reported that some time post port implant, the patient allegedly experienced allergic reaction, fibrin sheath and blood clot were formed due to heparin reaction. Therefore, the patient received prescribed medication. Reportedly, the device was replaced. Patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006260740-2020-00929
MDR Report Key9857807
Report SourceCONSUMER,OTHER
Date Received2020-03-19
Date of Report2020-03-19
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJUDITH LUDWIG
Manufacturer Street1415 W. 3RD STREET
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1BARD REYNOSA S.A. DE C.V.
Manufacturer StreetBLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL
Manufacturer CityREYNOSA TAMAULIPAS 88780
Manufacturer CountryMX
Manufacturer Postal Code88780
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOWERPORT MRI ISP ALTERNATIVE BUMPLS, 8F CHRONOFLEX, W SP
Generic NameIMPLANTABLE PORT
Product CodeLJT
Date Received2020-03-19
Model Number4808060
Catalog Number4808060
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBARD ACCESS SYSTEMS
Manufacturer Address605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-03-19

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