MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-08 for DANTEC CONCENTRIC NEEDLE ELECTRODE 9013S0032 manufactured by Natus Manufacturing Ltd..
[132360176]
Device (needle and cable) requested to be returned for evaluation. Further information about the reported issue has been requested, e. G. Lot number. Doc-010782 risk management report for dantec dcn was reviewed. Potential hazard and hazardous situation identified associated with physical injury - needle stick, id 23 (needles are sharp, users could pierce themselves) and physical injury - cannula & hub assembly separates from outer colour cover id 29 (needle / hub sub-assembly may pull out of outer colour cover). The overall risk rating is 3a (low - green area) (severity of hazard - 3 - moderate, probablility of hazard - a - unlikely). Justification for not providing below information and applicable sections: patient information - no patient injury reported, device malfunction occurred. Date of event - this information was requested from the customer and waiting for a response. Lot number has not been provided, this information has been requested from the customer and waiting for a response. Expiration date - waiting on lot number before expiration date can be established. (lot # required to view the dhr) udi - waiting on lot number before udi can be established. (lot # required to view the dhr) 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. Manufacturer date - waiting on lot number before manufacturer date can be established. (lot # required to view the dhr) 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
[132360177]
Faulty part: problem between the hub of a needle (b)(4) and the cable. Lot number unknown. "some emg needles of the old order are defective!! You can see on the picture taken by the doctor that the needle is detached from its base. " no patient or user injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2019-00001 |
| MDR Report Key | 8225709 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-08 |
| Date of Report | 2019-03-06 |
| Date Mfgr Received | 2018-12-24 |
| Date Added to Maude | 2019-01-08 |
| 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 LTD |
| 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 | 2019-01-08 |
| Model Number | 9013S0032 |
| Catalog Number | 9013S0032 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LTD. |
| Manufacturer Address | IDA BUSINESS PARK GORT GALWAY, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-08 |