BAG SET, 0500ML, WITH ENFIT CONNECTOR INF0500-A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-26 for BAG SET, 0500ML, WITH ENFIT CONNECTOR INF0500-A manufactured by Moog Medical Devices Group.

Event Text Entries

[58413462] The device in question is new to the market. It is one of the first enteral bag/administration sets to incorporate the new enfit connectors, which were specifically designed to be exclusively compatible with enteral feeding tubes. (b)(4) is one of the first companies to bring enfit connector-containing products to the market, but others will shortly follow suit. In fact, the enfit connectors are scheduled to become the industry standard over the course of 2015, with the older christmas-tree-style connectors scheduled to be phased out of the industry by early 2016. Since the introduction of the new enfit connector-containing enteral feeding sets earlier this year, (b)(4) has received a number of complaints about the new sets, the most common being that they leak in the vicinity of the purple enfit connector piece and the white transitional stepped connector. No injury to a patient was alleged in this particular complaint, and (b)(4) has not received any additional information indicating that a patient was or may have been harmed as a result of the reported event. (b)(4) would not normally submit an mdr for this event, but is doing so now because this particular issue (leaky enfit connector) has caused a reportable injury to a patient within the last two years. The complainant did not return the affected set(s) for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[58413463] The initial reporter stated that the administration set was "leaking from the white connector. " there was no adverse events or delay in therapy reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1722139-2016-00587
MDR Report Key6058006
Report SourceCONSUMER
Date Received2016-10-26
Date of Report2016-09-27
Date of Event2016-09-27
Date Mfgr Received2016-09-27
Device Manufacturer Date2015-10-28
Date Added to Maude2016-10-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKRISTIN HARDESTY
Manufacturer Street4314 ZEVEX PARK LANE
Manufacturer CitySALT LAKE CITY UT 84123
Manufacturer CountryUS
Manufacturer Postal84123
Manufacturer Phone8012641001
Manufacturer G1MOOG MEDICAL DEVICES GROUP, SRL
Manufacturer StreetCOYOL FREE ZONE AND BUSINESS PARK
Manufacturer CityALAJUELA, SAN JOSE 20113
Manufacturer CountryCS
Manufacturer Postal Code20113
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number1722139-11/19/15-001-C
Event Type3
Type of Report3

Device Details

Brand NameBAG SET, 0500ML, WITH ENFIT CONNECTOR
Generic NameENTERAL FEEDING SET
Product CodePIO
Date Received2016-10-26
Model NumberINF0500-A
Catalog NumberINF0500-A
Lot NumberNOT PROVIDED
OperatorPATIENT FAMILY MEMBER OR FRIEND
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMOOG MEDICAL DEVICES GROUP
Manufacturer Address4314 ZEVEX PARK LANE SALT LAKE CITY UT 84123 US 84123


Patients

Patient NumberTreatmentOutcomeDate
10 2016-10-26

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