MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-07 for DANTEC CONCENTRIC NEEDLE ELECTRODE 9013S0012 manufactured by Natus Manufacturing Limited.
[76970349]
Applicable work order was reviewed. In process testing and inspections were reviewed - hub id, hub to cover, hub to cannula. All samples taken for these tests gave acceptable results. No non-conformances, reworks related to this lot. All checks were completed as required by the process and quality plan for the dantec needle. Customer has been contacted via email with questionnaire to provide the rest of the required information below. The following information have not been provided and have been noted by the customer not relevant since there was no interaction with patient: patient identifier - not applicable, age at the time of event, date of birth - not applicable, sex - not applicable, weight - not applicable, relevant tests/laboratory data, including dates - not applicable, other relevant history, including preexisting medical conditions (e. G. , allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc. ) - not applicable. Concomitant medical products and therapy dates (excludes treatment of event) - not applicable. Justification for not providing below information and applicable sections: serial # - this section is not applicable as the medical device does not have serial #, if implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable, if explanted date (mm/dd/yyyy) - 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, if ind, give protocol # - this section is not applicable as the medical device is not ind, adverse event term(s) - 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 21 usc 360i(f). Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[76970350]
Issue with the hub of the 9013s0012: when customer tried to remove the needle, the needle and metal hub came away from the coloured plastic cover but not the needle. No patient impact as the attempt to disconnect needle from the cable happened after the testing has been completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2017-00005 |
| MDR Report Key | 6619206 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-07 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2017-06-26 |
| Device Manufacturer Date | 2016-10-11 |
| Date Added to Maude | 2017-06-07 |
| 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. MIA DUDICOVA |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | GORT, CO.GALWAY H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer Phone | 53 9164743 |
| Manufacturer G1 | NATUS MANUFACTURING LIMITED |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | GORT, CO. GALWAY 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 | CONCENTRIC NEEDLE ELECTRODE |
| Product Code | IKT |
| Date Received | 2017-06-07 |
| Model Number | 9013S0012 |
| Catalog Number | 9013S0012 |
| Lot Number | 41C/16/D |
| Device Expiration Date | 2019-10-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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, H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-07 |