MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-12-14 for TECA ELITE NEEDLE S53156 manufactured by Natus Manufacturing Ltd.
[130472747]
Customer reported 3 cases where hub separation occurred. It is 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 will be clarified. Justification for not providing below information and applicable sections: part a: patient information - no patient injury initially reported, device malfunction occurred. This will be confirmed. Date of event - date of event unknown, this information will be requested. 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 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
[130472748]
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 | 3005581270-2018-00017 |
| MDR Report Key | 8165180 |
| Report Source | OTHER |
| Date Received | 2018-12-14 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-09-08 |
| Date Mfgr Received | 2018-11-09 |
| Device Manufacturer Date | 2017-11-07 |
| Date Added to Maude | 2018-12-14 |
| 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 | 2018-12-14 |
| 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 | 2018-12-14 |