MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-03 for TECA ELITE NEEDLE S53153 manufactured by Natus Manufacturing Limited.
[115904707]
Manufacturers initial investigation: device history record will be reviewed. The defect product was not returned to the manufacturer. The customer returned the remainder of the unopened needles. These will be evaluated. Justification for not providing below information and applicable sections: patient information - no patient injury reported, device malfunction occurred. 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. 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 remedial action initiated , check type - this section is not applicable as no remedial action was initiated. There was no action reported under 21usc 360i(f).
Patient Sequence No: 1, Text Type: N, H10
[115904708]
Hub and cannula separation from colour cover. A red emg needle came out of its protective cylinder while performing an emg, the needle came loose from the red housing on the s53153 teca concentric needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2018-00006 |
| MDR Report Key | 7746082 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-03 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-07-13 |
| Date Mfgr Received | 2018-07-13 |
| Date Added to Maude | 2018-08-03 |
| 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 | TECA ELITE NEEDLE |
| Generic Name | TECA ELITE DISPOSABLE CONCENTRIC NEEDLE ELECTRODES |
| Product Code | IKT |
| Date Received | 2018-08-03 |
| Model Number | S53153 |
| Catalog Number | S53153 |
| Lot Number | 46B/17/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 LIMITED |
| Manufacturer Address | IDA BUSINESS PARK GORT GALWAY, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-03 |