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.
[27201688]
Registered internally as a complaint ((b)(4)) for investigation purposes. Needle not being returned for investigation, further information about complaint has been requested from customer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[27201689]
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 ((b)(4)) this report 3005581270-2015-00005 is one of three, 3005581270-2015-00006 and 3005581270-2015-00007.
Patient Sequence No: 1, Text Type: D, B5
[61014788]
Date of this report - corrected to 09/02/2015 (when reported to company) from 09/14/2015. Justification for not providing below information and applicable sections: serial # - this section is not applicable as the medical device does not have serial #. Implant date: if implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. Explant date: if explanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. Preprocessor name and address - this section is not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient. If ind, give protocol # - this section is not applicable as the medical device is not ind. Adverse event term(s) - this section is not applicable to medical devices. If remedial action initiated, check type - this section is not applicable as no remedial action was initiated if action reported to fda under 21 usc 360i(f), list correction/removal reporting number - this section is not applicable as there was no action reported under 21 usc 360i(f). 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 | 3005581270-2015-00005 |
| MDR Report Key | 5116206 |
| 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 |