MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-02-10 for TECA ELITE NEEDLE S53158 manufactured by Natus Manufacturing Limited.
[67113769]
The applicable work order was reviewed. No non conformances noted, all tests have passed our inspection criteria. Hub to cover retention tests were reviewed, all results are well above the minimum specified value - no unusual results for this test. Customer has been contacted to provide the rest of the required information below. Sections that are awaiting customer feedback. Date of event - awaiting response from customer. Device availability - awaiting response from customer. Actual device has not been returned yet.
Patient Sequence No: 1, Text Type: N, H10
[67113770]
Doctor is having some needles come apart at the hub.
Patient Sequence No: 1, Text Type: D, B5
[70575184]
Manufacturer narrative no issues with the production of this lot of needle electrodes. The device was found to have met specifications prior to shipment. No manufacturing anomalies were identified that may have caused or contributed to the reported malfunction. This is the first malfunction reported for this lot number to date. The result of the investigation is inconclusive as the device was not returned for evaluation. It has been reported that the device separated at the hub. Based upon the available information a definitive root cause cannot be determined. Date of event (mm/dd/yyyy) - the exact date of event is not known, event occured in (b)(6) 2017. Unique identifier (udi) # - primary identifier is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005581270-2017-00002 |
| MDR Report Key | 6321476 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-10 |
| Date of Report | 2017-01-12 |
| Date Mfgr Received | 2017-02-13 |
| Device Manufacturer Date | 2016-09-30 |
| Date Added to Maude | 2017-02-10 |
| 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 | MR. MICHAEL GALVIN |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | GORT, CO. GALWAY H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer Phone | 91 647451 |
| 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 | TECA ELITE NEEDLE |
| Generic Name | TECA ELITE DISPOSABLE CONCENTRIC NEEDLE |
| Product Code | IKT |
| Date Received | 2017-02-10 |
| Model Number | S53158 |
| Catalog Number | S53158 |
| Lot Number | 38A/16/T |
| Device Expiration Date | 2019-09-30 |
| 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, CO. GALWAY H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-10 |