MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-13 for BO-JECT NEEDLE ELECTRODE 9013S0442 manufactured by Natus Manufacturing Limited.
[130213740]
Work order and needle retains of the same lot have been pulled and is with quality and engineering. Questionnaire sent to the customer requesting further information about the event and requested the return of the defect product for evaluation. Justification for not providing below information and applicable sections: a. Patient information - patient information has been requested form the customer, waiting on a response. Relevant tests / laboratory data - this information was requested from the customer but no information has yet been provided. Other relevant history, including preexisting medical conditions - this information was requested from the customer but no information has yet been provided. Serial # - this section is not applicable as the medical device does not have a serial number. The medical device is not implantable. Reprocessor 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. Concomitant medical products and therapy dates (excluding treatment of event) - this section is not applicable to this type of device. Health professional? - this information ahs been requested, waiting a response. Occupation - this information ahs been requested, waiting a response. For use by user facility / importer - not applicable as we are not a facility or importer of device. If nd, give protocol # - this section is not applicable as the medical device is not ind. Adverse event terms - 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 21usc 360i(f).
Patient Sequence No: 1, Text Type: N, H10
[130213741]
Faulty part : part # 9013s0422 and lot # 1803ll04. The doctor was using a boject disposable hypodermic needle electrode with the clavis. The needle broke off while in the patient. The (b)(6) hospital request to return 7 boxes of item #9013s0422 hypodermic electrode needle due to patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2018-00016 |
| MDR Report Key | 8160267 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-13 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2018-12-04 |
| Device Manufacturer Date | 2018-03-14 |
| Date Added to Maude | 2018-12-13 |
| 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 | MS LOUISE CALLANAN |
| Manufacturer Street | IDA BUISNESS PARK GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer G1 | NATUS MANUFACTURING LTD. |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BO-JECT NEEDLE ELECTRODE |
| Generic Name | BO-JECT DISPOSABLE HYPODERMIC NEEDLE ELECTRODES |
| Product Code | IKT |
| Date Received | 2018-12-13 |
| Model Number | 9013S0442 |
| Catalog Number | 9013S0442 |
| Lot Number | 1803LL04 |
| 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 | 2018-12-13 |