MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-10-01 for DISPOSABLE TECA CONCENTRIC NEEDLE S53153 manufactured by Natus Manufacturing Limited.
[27202293]
Registered internally as a complaint (reference (b)(4)) for investigation purposes. Needle not being returned for investigation, further information about complaint has been requested from customer. The device history record for (b)(4) lot 22c/15/t has been obtained and reviewed. In process testing and inspections were reviewed. All samples taken for testing gave an acceptable result. No issues were noted. All checks were completed as required by the process and quality plan for teca concentric needle. No rework or sort performed on this lot. No ncr's noted for this lot. The customer complaints log was reviewed for the last 12 months and there has been one other complaint opened for this issue (reference (b)(4)) but was not for the same lot. Retains for this lot have been received and hub to colour cover retention testing was completed. All results were within the specification of 1. 2 kgf. Device not being returned.
Patient Sequence No: 1, Text Type: N, H10
[27202294]
Hub and needle separated on some needles. There have been 3 needles that separated from the hub. The colored cover separated from the metal hub. This occurred after multiple sticks (needle insertions) and when the dr. Unhooked the needle to dispose of it. The doctor was not stuck by this needle. There are 3 reports associated with the above complaint (ref (b)(4)) this report 3005581270-2015-00006 is one of three, 3005581270-2015-00005 and 3005581270-2015-00007.
Patient Sequence No: 1, Text Type: D, B5
[61003286]
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 | 3005581270-2015-00006 |
| MDR Report Key | 5116203 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-10-01 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2015-09-04 |
| Device Manufacturer Date | 2015-05-28 |
| Date Added to Maude | 2015-10-01 |
| 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 | 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 | DISPOSABLE TECA CONCENTRIC NEEDLE |
| Generic Name | ELECTRODE |
| Product Code | GXZ |
| Date Received | 2015-10-01 |
| Model Number | S53153 |
| Catalog Number | S53153 |
| Lot Number | 22C/15/T |
| Device Expiration Date | 2018-05-30 |
| 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 MANUFACTURING LIMITED |
| Manufacturer Address | IDA BUSINESS PARK GORT GALWAY, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-01 |