POLYUR FEED TUBE 3.5 FR X 12 461355

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-03-26 for POLYUR FEED TUBE 3.5 FR X 12 461355 manufactured by Covidien.

Event Text Entries

[186020650] The incident sample has been requested but to date has not been received for evaluation.? If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.? As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10


[186020651] The customer reported that they observed a small pinpoint break beneath the hub of the feeding tube. The tube was removed and replaced with a new feeding tube. This occurred in the nicu of the hospital. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612030-2020-02442
MDR Report Key9886084
Report SourceHEALTH PROFESSIONAL,OTHER,USE
Date Received2020-03-26
Date of Report2020-03-26
Date Mfgr Received2020-03-17
Date Added to Maude2020-03-26
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 StreetCALLE 9 SUR NO. 125 CUIDAD IND
Manufacturer CityTIJUANA 22500
Manufacturer CountryMX
Manufacturer Postal Code22500
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLYUR FEED TUBE 3.5 FR X 12
Generic NameTUBES, GASTROINTESTINAL (AND ACCESSORIES)
Product CodeKNT
Date Received2020-03-26
Model Number461355
Catalog Number461355
Lot Number1911339964
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressCALLE 9 SUR NO. 125 CUIDAD IND TIJUANA 22500 MX 22500


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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