MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-12-18 for TECA ELITE NEEDLE S53156 manufactured by Natus Manufacturing Ltd.
[131005717]
Customer has reported 3 cases. On initial report it was not known if the 3 cases were of the same part number and lot number, or if the needles were used on the same patient or 3 different patients. This information was clarified by the customer on the (b)(6) 2018. The 3 incidents involved the part number s53156 and lot number 45b/17/t. This occurred after use on 3 different patients. The three incidents will be investigated under complaints and adverse event numbers: (b)(4). Justification for not providing below information and applicable sections: patient information - no patient injury initially reported, device malfunction occurred. This will be confirmed. 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. 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
[131005718]
Hub separation needle issue. Defective needles, the plastic protector is released when the cable is disconnected and the needle remains connected to the needle holder. Customer has reported 3 cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2018-00019 |
| MDR Report Key | 8173564 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-12-18 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-09-08 |
| Date Mfgr Received | 2018-11-09 |
| Device Manufacturer Date | 2018-11-07 |
| Date Added to Maude | 2018-12-18 |
| 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 | 2018-12-18 |
| Model Number | S53156 |
| Catalog Number | S53156 |
| Lot Number | 45B/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 LTD |
| Manufacturer Address | IDA BUSINESS PARK GORT GALWAY, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-18 |