MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-21 for TECA ELITE NEEDLE S53153 manufactured by Natus Manufacturing Ltd..
[121715427]
Work order (b)(4) was reviewed. (b)(4) was referenced in relation to humidity failure in the cleanroom. In process testing and inspections recorded on doc-011247 rev g all gave pass results. The results for hub to cover retention test were within specification which is minimum 1. 2kgf. Lowest value recorded was 2. 490kgf, highest recorded value was 9. 235kgf. No reworks carried out on this lot. Defect product has been requested to be returned. Justification for not providing below information and applicable sections: patient information - no patient injury reported, device malfunction occurred. Date of event - date of event requested from the customer but information 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. Suspect products - not applicable. Serial # - this section is not applicable as the medical device does not have a serial number. 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. Concomitant medical products and therapy dates (excluding treatment of event) - this section is not applicable to this type of device for use by user facility / importer - 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 21 usc 360i(f).
Patient Sequence No: 1, Text Type: N, H10
[121715428]
Teca concentric needle hub to colour separation. Teca concentric s53153 (1 box), red casing around the needle is coming off on every single needle on this box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2018-00011 |
| MDR Report Key | 7897219 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-21 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-08-28 |
| Date Mfgr Received | 2018-08-22 |
| Device Manufacturer Date | 2018-03-14 |
| Date Added to Maude | 2018-09-21 |
| 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 | TECA ELITE NEEDLE |
| Generic Name | TECA ELITE DISPOSABLE CONCENTRIC NEEDLE ELECTRODE |
| Product Code | IKT |
| Date Received | 2018-09-21 |
| Model Number | S53153 |
| Catalog Number | S53153 |
| Lot Number | 11B/18/T |
| 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 | 2018-09-21 |