CONN FILTER TO TUBING MEGAVAC 2140J

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-31 for CONN FILTER TO TUBING MEGAVAC 2140J manufactured by Megadyne Medical Products, Inc..

Event Text Entries

[115771904] (b)(4). Investigation summary received (b)(4) each of 2140j of lot number 183199. In addition, two photos were returned and reviewed. The investigation confirmed that the product inside of the sealed packages did not match the photo of the packaging. There was no thread on one end of the device and the incorrect type of connector on the other end of the device. This was also confirmed by the two photos returned. A review of the dhr shows this product was originally manufactured to specifications and there is no evidence of device defect or malfunction.
Patient Sequence No: 1, Text Type: N, H10


[115771905] It was reported that when the customer received their orders for product code 2140j that the pictures on the product labels are correct but the product that is inside the packages is not what they ordered. The adapters are different than the devices they previously ordered under the product code of 2140. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721194-2018-00026
MDR Report Key7736983
Date Received2018-07-31
Date of Report2018-07-03
Date of Event2018-01-03
Date Mfgr Received2018-07-03
Device Manufacturer Date2018-05-21
Date Added to Maude2018-07-31
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 ContactMILT GARRETT
Manufacturer Street11506 SOUTH STATE STREET
Manufacturer CityDRAPER UT 84020
Manufacturer CountryUS
Manufacturer Postal84020
Manufacturer G1IC MEDICAL INC.
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCONN FILTER TO TUBING MEGAVAC
Generic NameCONNECTOR FILTER TO TUBING MEGA VAC
Product CodeFYD
Date Received2018-07-31
Returned To Mfg2018-07-17
Catalog Number2140J
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEGADYNE MEDICAL PRODUCTS, INC.
Manufacturer Address11506 SOUTH STATE STREET DRAPER UT 84020 US 84020


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-31

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