HD CATHETER REPAIR KIT 8888200001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-05-30 for HD CATHETER REPAIR KIT 8888200001 manufactured by Arglye (sheridan).

Event Text Entries

[15322079] It was reported to covidien on (b)(4) 2014 that a customer had an issue with a dialysis repair kit. The customer states that the venous connector line of the device was defective, the tip was broken and a circuit leakage was noticed. The device was pulled and replaced.
Patient Sequence No: 1, Text Type: D, B5


[15636118] An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1317749-2014-00238
MDR Report Key3879551
Report Source01,06
Date Received2014-05-30
Date of Report2014-05-02
Date of Event2014-04-18
Date Mfgr Received2014-05-02
Date Added to Maude2014-07-02
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 Location0
Manufacturer ContactLAWRENCE ROCK
Manufacturer Street15 HAMPSHIRE STREET
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 NameHD CATHETER REPAIR KIT
Generic NameREPAIR KIT
Product CodeNYU
Date Received2014-05-30
Model Number8888200001
Catalog Number8888200001
Lot Number229101X
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerARGLYE (SHERIDAN)
Manufacturer Address5439 STATE ROUTE 40 ARGYLE NY 12809 US 12809


Patients

Patient NumberTreatmentOutcomeDate
10 2014-05-30

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