MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-15 for DISPOSABLE TECA CONCENTRIC NEEDLE S53153 manufactured by Natus Mnaufacturing Limited.
[40327098]
Registered internally as a complaint (reference (b)(4)) for investigation purposes. Needle not being returned for investigation, all relevant information given in description of event. The device history record for (b)(4), lot49f/15/t has been obtained and reviewed. In process testing and inspections were reviewed. All samples taken gave an acceptable result. No issues were noted. All checks were completed as required by the process and quality plan for teca concentric needle. Device not being returned.
Patient Sequence No: 1, Text Type: N, H10
[40327099]
Cannula separation from the colour over occurred, with the metal hub remaining within the colour cover, as stated by customer: "the needle came away from the coloured plastic hub but the silver metal hub was still in the plastic hub. "
Patient Sequence No: 1, Text Type: D, B5
[61013730]
The following has been corrected: date of this report - corrected to 03/02/2016 (when reported to company) from 03/10/2016. Device manufacture date (mm/dd/yyyy) - corrected to 12/16/2015 from 12/16/2016. (b)(4). Customer has been contacted to provide the rest of the required information. We are in the process of gathering additional information. A letter listing outstanding information has been sent to customer to obtain additional information in order to submit follow up report and/or explain why required information was not provided and steps taken to obtain such information. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005581270-2016-00002 |
| MDR Report Key | 5500125 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-02 |
| Date of Event | 2016-02-25 |
| Date Mfgr Received | 2016-03-02 |
| Device Manufacturer Date | 2016-12-16 |
| Date Added to Maude | 2016-03-15 |
| 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 GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer Phone | 9164700 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE TECA CONCENTRIC NEEDLE |
| Generic Name | ELECTRODE |
| Product Code | GXZ |
| Date Received | 2016-03-15 |
| Model Number | S53153 |
| Catalog Number | S53153 |
| Lot Number | 49F/15/T |
| Device Expiration Date | 2018-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MNAUFACTURING LIMITED |
| Manufacturer Address | IDA BUISNESS PARK GORT GALWAY, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-15 |