PALINDROME EMERALD 23/40KIT VT 8888145044

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-11-02 for PALINDROME EMERALD 23/40KIT VT 8888145044 manufactured by Covidien.

Event Text Entries

[2957258] It was reported to covidien on (b)(6) 2012 that a customer had an issue with a dialysis catheter. The customer reports the catheter was inserted on (b)(6) 3012. The catheter cracked above the hub on (b)(6) 2012 and exchanged on that same day.
Patient Sequence No: 1, Text Type: D, B5


[10330602] (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 Number1317749-2012-00272
MDR Report Key2861184
Report Source01,05,06
Date Received2012-11-02
Date of Report2012-10-29
Date of Event2012-07-12
Report Date2012-10-29
Date Reported to Mfgr2012-10-29
Date Mfgr Received2012-10-29
Date Added to Maude2012-12-21
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 ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
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 23/40KIT VT
Generic NameDIALYSIS CATHETER
Product CodeNYU
Date Received2012-11-02
Model Number8888145044
Catalog Number8888145044
Lot Number007107
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2012-11-02

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