MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-08-03 for TECA ELITE NEEDLE S53153 manufactured by Natus Manufacturing Limited.
[51027394]
Dhr was obtained and reviewed. All in-process tests an d inspections completed. No untoward results noted. Packaging form for labels and reconciliation was reviewed no issues noted. Record of inspection during secondary packaging form was reviewed. Sample size of (b)(4) pouches inspected, all results passed inspection. Multivac in-process test form was reviewed, visual inspection results all passed, seal strength results within specification. No other untoward issues were associated with this lot. All operators for this process have been notified of the issue and shown pictures of the defective pouched needles to make them aware the event occurred.
Patient Sequence No: 1, Text Type: N, H10
[51027395]
This customer complaint is related to report 300581270-20016-0005 as they were reported at the same time. Customer narrative is as follows: 'another incident they feedback to us is there is one pack of teca elite dcn needle, inside the packaging there is 2 pcs of needle cap'.
Patient Sequence No: 1, Text Type: D, B5
[61015334]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005581270-2016-00006 |
| MDR Report Key | 5842608 |
| Report Source | OTHER |
| Date Received | 2016-08-03 |
| Date of Report | 2016-07-11 |
| Date of Event | 2016-07-07 |
| Date Mfgr Received | 2016-07-12 |
| Device Manufacturer Date | 2014-10-31 |
| Date Added to Maude | 2016-08-03 |
| 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 |
| Manufacturer Country | EI |
| Manufacturer G1 | NATUS MANUFACTURING LIMITED |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | GORT, CO GALWAY |
| Manufacturer Country | EI |
| 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 | 2016-08-03 |
| Model Number | S53153 |
| Catalog Number | S53153 |
| Lot Number | 43A/14/TG |
| Device Expiration Date | 2017-10-31 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| 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, CO GALWAY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-03 |