MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-01-14 for DISPOSABLE TECA CONCENTRIC NEEDLE S53156 manufactured by Natus Manufacturing Limited.
[36054131]
The retains log for this sn stated that this lot of needles had been taken for testing for a separate complaint, cc001300. This complaint states that there were burrs in the needles. All 25 retain needles were tested and no issues were noted. This work order has been reviewed and the seal strength test results have been investigated. The specification for a pass in seal strength is 1. 2n, the results ranged from 2. 508n - 3. 446n for this lot which is above specification. Stock was checked on oracle for this lot number. No lots are in stock. Calibration of multitest1-d, unit to test seal strength for needle packaging, was found to be up to date. Reached out three times (18 dec, 21 dec and 04 jan) to sales rep to get more information from the complainant about the complaint. Sales rep has contacted complainant but hasn't had any response as of jan 08th.
Patient Sequence No: 1, Text Type: N, H10
[36054132]
When doctor went ot use needle, the needle pouch was not sealed, open pouch in box.
Patient Sequence No: 1, Text Type: D, B5
[60922386]
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. Device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005581270-2016-00001 |
| MDR Report Key | 5367593 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-01-14 |
| Date of Report | 2015-12-17 |
| Date of Event | 2015-12-17 |
| Date Mfgr Received | 2015-12-17 |
| Device Manufacturer Date | 2015-04-08 |
| Date Added to Maude | 2016-01-14 |
| 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 | MR MICHAEL GALVIN |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer Phone | 539164700 |
| Manufacturer G1 | NATUS MNAUFACTURING 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 | 2016-01-14 |
| Model Number | S53156 |
| Catalog Number | S53156 |
| Lot Number | 13C/15/TG |
| Device Expiration Date | 2018-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-01-14 |