MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-16 for DANTEC CONCENTRIC NEEDLE ELECTRODE 9013S0032 manufactured by Natus Manufacturing Limited.
[105674927]
Manufacturers initial investigation: work order (b)(4) for lot 50c/17/d was reviewed. No rework or sort performed on this lot. No excessive scrap quantities noted. No ncr's related to this lot. In process testing and inspections recorded on (b)(4) were reviewed. All samples taken for tests gave acceptable results. The results for the hub to cover retention test were within specification which is minimun 1. 2kgf. Lowest value recorded was 1. 700kgf, highest recorded value was 6. 620kgf. The following test was carried out on a quantity of 10 needles (retains): hub to cover retention test as per (b)(4) - all needles passed with the results within minimum specifications of 1. 2kgf. Lowest value recorded was 1. 990kgf, highest recorded value was 4. 435kgf. Defective medical device has been returned to natus manufacturing ltd. Justification for not providing below information and applicable sections: part a: patient information - no patient injury reported, device malfunction occurred.
Patient Sequence No: 1, Text Type: N, H10
[105674928]
Hub and cannula separation from the colour cover. When pulling out the emg needle from the cable, the colour cover of the needle detached resulting in uncontrollable needle movement and risk of injury to users.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2018-00002 |
| MDR Report Key | 7432641 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-16 |
| Date of Report | 2018-07-12 |
| Date of Event | 2018-03-20 |
| Date Mfgr Received | 2018-03-21 |
| Device Manufacturer Date | 2017-12-15 |
| 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 | MS 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 |
| Remedial Action | OT |
| 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 |
| Returned To Mfg | 2018-03-29 |
| Model Number | 9013S0032 |
| Catalog Number | 9013S0032 |
| Lot Number | 50C/17/D |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |