3 GA RENEWABLES DIALYSIS 8964

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-28 for 3 GA RENEWABLES DIALYSIS 8964 manufactured by Covidien.

Event Text Entries

[181539940] The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Patient Sequence No: 1, Text Type: N, H10


[181539941] The customer reported that there were cracks on the lid and body of the container.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1424643-2020-00566
MDR Report Key9769610
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-02-28
Date of Report2020-02-28
Date of Event2020-02-20
Date Mfgr Received2020-02-27
Date Added to Maude2020-02-28
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086183640
Manufacturer G1COVIDIEN
Manufacturer Street815 TEK DRIVE
Manufacturer CityCRYSTAL LAKE IL 600399002
Manufacturer CountryUS
Manufacturer Postal Code600399002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3 GA RENEWABLES DIALYSIS
Generic NameCONTAINER, SHARPS
Product CodeMMK
Date Received2020-02-28
Model Number8964
Catalog Number8964
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address815 TEK DRIVE CRYSTAL LAKE IL 600399002 US 600399002


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-28

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