BARD? PREMATURE INFANT FEEDING TUBE 0036400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-19 for BARD? PREMATURE INFANT FEEDING TUBE 0036400 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[103020597] The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10


[103020598] It was reported that a patient had been struggling with breastfeeding her baby, attempting multiple times during a nurse's shift. The patient had been set up with a nipple shield, feeding tube and syringe to assist her in feeding her newborn. After multiple attempts to feed the newborn, it was noticed that the newborn was still unable to intake the supplemental formula from the feeding tube and syringe. Upon further inspection of the feeding tube, the nurse noticed that the tube had only one hole at the end of it instead of two. The infant was not able to suck the supplemental formula from the device. Per additional information: the mother was trying to breastfeed and use the device at the same time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2018-00863
MDR Report Key7350173
Date Received2018-03-19
Date of Report2018-04-05
Date Mfgr Received2018-04-04
Device Manufacturer Date2017-05-06
Date Added to Maude2018-03-19
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 ContactAMY GRAVLEY
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBARD? PREMATURE INFANT FEEDING TUBE
Generic NameFEEDING TUBE
Product CodeFPD
Date Received2018-03-19
Model Number0036400
Catalog Number0036400
Lot NumberNGBR3192
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-19

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