EPUMP INTL 1000ML FD AND FLUSH 673662

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-24 for EPUMP INTL 1000ML FD AND FLUSH 673662 manufactured by Covidien.

Event Text Entries

[184870695] 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.? As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.? 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


[184870696] The customer reported that during priming, the device presented nutrition leak due to perforation or hole between the bag and the administration line. There was no patient involved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1282497-2020-08987
MDR Report Key9871759
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-03-01
Date Mfgr Received2020-03-19
Date Added to Maude2020-03-24
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 Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal Code02048
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEPUMP INTL 1000ML FD AND FLUSH
Generic NamePUMP, INFUSION, ENTERAL
Product CodeLZH
Date Received2020-03-24
Model Number673662
Catalog Number673662
Lot Number192420022
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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