PPRT MRI ISP 8GR INT 9808560

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for PPRT MRI ISP 8GR INT 9808560 manufactured by Bard Access Systems.

Event Text Entries

[184757373] Medical images were provided for review. As the lot number for the device was not provided, a review of the device history records could not be performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[184757414] It was reported that approximately three years, eight months and twelve days post port implant via the right internal jugular vein, during anticancer agent infusion, the device was allegedly unable to aspirate. It was further reported that during saline infusion, swelling and subcutaneous leak were allegedly identified. Therefore, the x-ray examination was performed which demonstrated catheter break and migration of the distal catheter segment near the pulmonary artery. Reportedly, distal catheter segment was removed. The patient was reported as stable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006260740-2020-00970
MDR Report Key9866792
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-02-18
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-23
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 NamePPRT MRI ISP 8GR INT
Generic NameIMPLANTABLE PORT
Product CodeLJT
Date Received2020-03-23
Model Number9808560
Catalog Number9808560
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 2020-03-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.