MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-10 for DANTEC CONCENTRIC NEEDLE ELECTRODE 9013S0012 manufactured by Natus Manufacturing Limited.
[108291129]
Work order (b)(4) was reviewed. No ncr's or reworks associated with this lot. Approved production restart form (b)(4) was present in relation to the grinder m/c 908 - full coolant change. In process testing and inspections were reviewed - hub to cover retention test readings ranging between 2. 845 - 6. 875 kgf, hub to cannula tensile test ranging from 11. 72 - 17. 14 ibf. All results were acceptable and recorded on (b)(4). Medisize (supplier of colour covers) inprocess inspection results for hub to colour cover retention were reviewed. Two lots of colour covers were used on this batch of needles, lots 17051420 and 17055420. Lowest value recorded for lot 17051420 was 3. 167 and highest was 8. 195 (spec 1. 2kgf) lowest value recorded for lot 17055420 was 2. 760 and highest was 8. 322. (spec 1. 2kgf). Date of event requested from the customer but not yet provided relevant tests / laboratory data - this section is not applicable as no patient injury occurred. Other relevant history, including preexisting medical conditions: this section is not applicable as no patient injury occurred. Serial # - this section is not applicable as the medical device does not have a serial number. This section is not applicable as the medical device is not implantable. Reprocessor name and address - this section is not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient. Concomitant medical products and therapy dates (excluding treatment of event) - this section is not applicable to this type of device not applicable as we are not a facility or importer of device. If nd, give protocol # - this section is not applicable as the medical device is not ind. Adverse event terms - this section is not applicable to medical devices. If remedial action initiated , check type - this section is not applicable as no remedial action was initiated. If action reported to fda under 21 usc 360i (f), list correction / removal reporting number - this section is not applicable as there was no action reported under 21usc 360i(f).
Patient Sequence No: 1, Text Type: N, H10
[108291130]
Hub and cannula separation from colour cover during removal of connector cable. "when pulling out the emg needle, the plastic socket detached at the connection of the emg needle to the lead cable, resulting in uncontrollable needle movement, danger of injury with potential risk of infection for users. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2018-00004 |
| MDR Report Key | 7501818 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-10 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2018-04-13 |
| Device Manufacturer Date | 2017-05-22 |
| Date Added to Maude | 2018-05-10 |
| 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 | 2018-05-10 |
| Returned To Mfg | 2018-04-18 |
| Model Number | 9013S0012 |
| Catalog Number | 9013S0012 |
| Lot Number | 21A/17/D |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-05-10 |