BAG SET, 1200ML, ENFITCONNECTOR INF1200-A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-10-22 for BAG SET, 1200ML, ENFITCONNECTOR INF1200-A manufactured by Moog Medical Devices Group.

Event Text Entries

[125117115] The device was not returned to mmdg for evaluation. A dhr was performed and found no non-conformances during the build. Because it was not returned, mmdg has been unable to investigate or confirm the complaint.
Patient Sequence No: 1, Text Type: N, H10


[125117116] The initial reporter states that the "bags were not working". They stated that the pump was running, but "formula would not go through the bag". Mmdg followed up with the initial reporter, who stated that the patient only received part of their feeding due to the formula not delivering, but that the patient was doing well afterwards, and had not had any adverse effects. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1722139-2018-00252
MDR Report Key7991708
Report SourceUSER FACILITY
Date Received2018-10-22
Date of Report2018-09-27
Date of Event2018-09-01
Date Mfgr Received2018-09-27
Device Manufacturer Date2018-06-14
Date Added to Maude2018-10-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBAG SET, 1200ML, ENFITCONNECTOR
Generic NameENTERAL FEEDING SET
Product CodePIO
Date Received2018-10-22
Model NumberINF1200-A
Catalog NumberINF1200-A
Lot NumberCF1815911
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 2018-10-22

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