Brand Name | PVC ENTERAL FEEDING TUBE WITH ENFIT CONNECTOR, PURPLE 8FR X 40CM |
Type of Device | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
Manufacturer (Section D) |
NEOMED, INC |
100 londonderry court |
suite 112 |
woodstock GA 30188 |
|
MDR Report Key | 8425613 |
MDR Text Key | 139185893 |
Report Number | 3006520777-2019-00002 |
Device Sequence Number | 1 |
Product Code |
KNT
|
UDI-Device Identifier | 00817584011243 |
UDI-Public | 0100817584011243172009061020170907 |
Combination Product (y/n) | N |
PMA/PMN Number | K120182 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Source Type |
health professional,user faci |
Type of Report
| Initial,Followup |
Report Date |
06/28/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/15/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/06/2020 |
Device Model Number | PFTS8.0V-NC |
Device Catalogue Number | PFTS8.0V-NC |
Device Lot Number | 20170907 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/20/2019 |
Was the Report Sent to FDA? |
Yes
|
Distributor Facility Aware Date | 02/13/2019 |
Event Location |
Hospital
|
Date Manufacturer Received | 02/13/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 22 DA |
|
|