MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-04-16 for DANTEC CONCENTRIC NEEDLE ELECTRODE 9013S0012 manufactured by Natus Manufacturing Limited.
[105763877]
Work order (b)(4) was reviewed. No rework or sort performed on this lot. No excessive scrap quantities were noted. No ncr's related to this lot. Accepted run at risk 180 - related to retest of environmental monitoring of cleanroom. Pq135 noted - validation of concentric needles on andmar grinder mc1917. Pq136 - protocol for visual inspection post electropolish. In process testing and inspections recorded on (b)(4) were reviewed. All samples taken for tests gave acceptable results. The results for hub to cover retention test were within specification which is minimum 1. 2kgf. Lowest value recorded was 2. 145kgf, highest recorded value was 6. 630kgf. The following test was carried out on a qty of 10 needles (retains): hub to cover retention test as per (b)(4) - all needles passed with results within minimum spec of 1. 2kgf. Lowest value recorded was 1. 605kgf, highest recorded value was 5. 530kgf. The problem device has not been returned, natus has received the remaining unopened needles of this lot number 48a/17/d.
Patient Sequence No: 1, Text Type: N, H10
[105763878]
Hub and cannula separation from the colour cover. A problem where the colour cover separates from the needle when removing the needle from the cable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2018-00003 |
| MDR Report Key | 7432650 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-16 |
| Date of Report | 2018-07-12 |
| Date Mfgr Received | 2018-03-21 |
| Device Manufacturer Date | 2017-11-27 |
| Date Added to Maude | 2018-04-16 |
| 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 Contact | MISS LOUISE CALLANAN |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer G1 | NATUS MANUFACTURING LIMITED |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91PD92 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DANTEC CONCENTRIC NEEDLE ELECTRODE |
| Generic Name | DANTEC DISPOSABLE CONCENTRIC NEEDLE |
| Product Code | IKT |
| Date Received | 2018-04-16 |
| Model Number | 9013S0012 |
| Catalog Number | 9013S0012 |
| Lot Number | 48A/17/D |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LIMITED |
| Manufacturer Address | IDA BUSINESS PARK GORT GALWAY, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-16 |