PALINDROME EMERALD 19/36 KIT VT 8888145043

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-05-29 for PALINDROME EMERALD 19/36 KIT VT 8888145043 manufactured by Covidien.

Event Text Entries

[17399193] It was reported to covidien on 05/22/2009, that a customer had an issue with a dialysis catheter. Customer states the pt came in with cracked hubs and the catheter need to be pulled and replaced.
Patient Sequence No: 1, Text Type: D, B5


[17661848] (b) (4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1317749-2009-00144
MDR Report Key1474638
Report Source05,06
Date Received2009-05-29
Date of Report2009-05-22
Report Date2009-05-22
Date Reported to Mfgr2009-05-22
Date Mfgr Received2009-05-22
Date Added to Maude2009-10-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactTHOM MCNAMARA
Manufacturer Street15 HAMPSHIRE ST.
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5082616625
Manufacturer G1COVIDIEN
Manufacturer Street5439 STATE ROUTE 40
Manufacturer CityARGYLE NY 12809
Manufacturer CountryUS
Manufacturer Postal Code12809
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePALINDROME EMERALD 19/36 KIT VT
Generic NameDIALYSIS CATHETER
Product CodeNYU
Date Received2009-05-29
Model Number8888145043
Catalog Number8888145043
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address5439 STATE ROUTE 40 ARGYLE NY 12809 US 12809


Patients

Patient NumberTreatmentOutcomeDate
10 2009-05-29

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