ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION 70-0060-220 SBRD-20-ENF

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-04-26 for ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION 70-0060-220 SBRD-20-ENF manufactured by Xeridiem Medical Devices.

Event Text Entries

[107221122] No patient information was available. Event date is estimated based upon report date (event date may be earlier). This mdr groups four complaints which are on the same model number and for the same issue. Model number is xeridiem part number. Catalog number is part number for (b)(4), xeridiem's exclusive distributor for this device. Since lot number is unknown, expiration date and full udi are not known. Implant/explant dates are not known. The device was returned on one of the four complaints with a possible return anticipated on one more. Date of return is estimated based on date of evaluation. A follow-up report will only be provided if there is a different finding on the last return. (b)(6). (b)(4). Evaluation completed on the return from one complaint. One more device return is anticipated. Date of manufacture cannot be determined since lot number is unknown. (b)(4). Xeridiem is presently working through production implementation of this change.
Patient Sequence No: 1, Text Type: N, H10


[107221123] The enfit caps and feeding port connections are breaking. There are small cracks in the caps themselves and the threaded flanges are breaking off. The patient is also using tools to get caps unstuck. The caps need to be tightened down hard or else they leak. The enfit that is glued into tube is breaking when patients try to wiggle the enfit connection out of the feeding ports.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2025851-2018-00009
MDR Report Key7464852
Report SourceDISTRIBUTOR
Date Received2018-04-26
Date of Report2018-04-27
Date of Event2018-03-02
Date Mfgr Received2018-03-02
Date Added to Maude2018-04-26
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 ContactMR. STEVE MURRAY
Manufacturer Street4700 S. OVERLAND DRIVE
Manufacturer CityTUCSON AZ 857143430
Manufacturer CountryUS
Manufacturer Postal857143430
Manufacturer Phone5208827794
Manufacturer G1XERIDIEM MEDICAL DEVICES
Manufacturer Street4700 S. OVERLAND DRIVE
Manufacturer CityTUCSON AZ 857143430
Manufacturer CountryUS
Manufacturer Postal Code857143430
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
Generic NameGASTROSTOMY TUBE
Product CodePIF
Date Received2018-04-26
Returned To Mfg2018-04-06
Model Number70-0060-220
Catalog NumberSBRD-20-ENF
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerXERIDIEM MEDICAL DEVICES
Manufacturer Address4700 S. OVERLAND DRIVE TUCSON AZ 857143430 US 857143430


Patients

Patient NumberTreatmentOutcomeDate
10 2018-04-26

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