BAG SET, 500ML, ENFITCONNECTOR INF0500-A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2016-03-15 for BAG SET, 500ML, ENFITCONNECTOR INF0500-A manufactured by Moog Medical Devices Group.

Event Text Entries

[40390719] 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. Moog 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, moog 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 moog has not received any additional information indicating that a patient was or may have been harmed as a result of the reported event. Moog 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. Mmdg will cease production of all its enteral administration sets using enfit connectors and transition back to the previous revision of the product codes that do not include the enfit connector (inf0020, inf0500, inf1200 and gr1200). The previous revision includes neither the enfit connector nor the transitional connector. This revision does not exhibit the same degree of leaking, nor has it experienced any adverse reaction to formula ingredients. Mmdg will produce the previous revision until a suitable solution to the enfit connector material degradation problem is found.
Patient Sequence No: 1, Text Type: N, H10


[40390720] The initial reporter stated the following: i am still experiencing multiple problems with these bags. Most of the time it is the clear hard plastic part that breaks in half now and will not allow the pump to distribute patient's liquid diet. More often now (about three times/month) the feed will leak out of the end of the tubing due to a crack in the 'purple' hard plastic end (that joins to the white hard plastic end). This week i had a small pin hole in the actual bag itself, but as long as i kept the bag upright, i was able to use the bag for the feeds. Unless i am able to gravity feed (which patient's high school will not do), the clear hard plastic breaking requires me to use a new bag. If the end has cracked (purple piece) i cannot use the bag either way. Reporter did not provide a specific date the event had occured; they just said it was an "ongoing" problem. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1722139-2016-00364
MDR Report Key5503117
Report SourceCONSUMER,DISTRIBUTOR,OTHER
Date Received2016-03-15
Date of Report2016-03-14
Date Mfgr Received2015-11-06
Device Manufacturer Date2013-08-09
Date Added to Maude2016-03-15
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. MATT BRINKERHOFF
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, 500ML, ENFITCONNECTOR
Generic NameENTERAL FEEDING SET
Product CodePIO
Date Received2016-03-15
Model NumberINF0500-A
Catalog NumberINF0500-A
Lot NumberCF1322107
Device Expiration Date2016-08-09
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 2016-03-15

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