MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-04 for NI 2000840 manufactured by Technimark.
[110367698]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[110367699]
It was reported that the graduation lines of an oral syringe were fading. The syringe was used for a twice daily dosing for one week (10-15 times) before the graduation line were nearly gone. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[113813398]
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[113813399]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-03367 |
| MDR Report Key | 7566063 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-04 |
| Date of Report | 2018-07-11 |
| Date Mfgr Received | 2018-06-26 |
| Date Added to Maude | 2018-06-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | TECHNIMARK |
| Manufacturer Street | KIRKCARRION ESTATE MIDDLETON-IN-TEESDALE |
| Manufacturer City | BARNARD CASTLE DL120TN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | DL12 0TN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NI |
| Generic Name | DISPENSER, LIQUID MEDICATION |
| Product Code | KYX |
| Date Received | 2018-06-04 |
| Model Number | NA |
| Catalog Number | 2000840 |
| Lot Number | 1613308 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECHNIMARK |
| Manufacturer Address | BARNARD CASTLE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-04 |