MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-16 for DANTEC CONCENTRIC NEEDLE ELECTRODE 9013S0032 manufactured by Natus Manufacturing Limited.
[102627234]
Manufacturers initial investigation: work order (b)(4) was reviewed. Run at risk 180 noted for retest of environmental monitoring carried out in the cleanroom. In process testing and inspections were reviewed - hub to cover retention test readings ranging between 1. 215 - 6. 580 kgf, hub to cannula tensile test ranging from 21. 13 - 32. 98 ibf. All results were acceptable and recorded on (b)(6). The following tests were completed on a qty of 7 needles (retains) as per (b)(6) rev d: hub to cover retention test: ranging between 2. 560 - 4. 750kgf - pass. Hub to cannula tensile test ranging between 23. 77 - 30. 98 ibf - pass. Customer completed the questionnaire and provided further information. Manufacturing engineer has reviewed customer response and has concluded: "colour cover separation after procedure when pulling the cable connector off the needle. Problem with colour cover too lose or connector too tight. " product return requested from the customer but the customer has already disposed of the defective part. Customer has been contacted to provide the rest of the required information below but the following information has not been provided to us. Patient weight, concomitant medical products and therapy dates (excluding treatment of event), customer has confirmed that there was no other relevant data in relation to other relevant history, including pre-existing medical conditions. Justification for not providing below information and applicable sections: serial # - this section is not applicable as the medical device does not have a serial number. If implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. If explanted date (mm/dd/yyyy) - this section is not applicable as 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. 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 21 usc 360i(f).
Patient Sequence No: 1, Text Type: N, H10
[102627235]
Part number: 9013s0032 dantec concentric needle, lot: 44b/17/d - needle disengaged and the doctor was hurt. In trying to disconnect the emg needle from the cable with the thumb and index finger, the plastic of the cover assembly slipped over the solid parts of the needle cranially, thereby a stitch in the thumb occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2018-00001 |
| MDR Report Key | 7345106 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-16 |
| Date of Report | 2018-03-12 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-02-15 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-03-16 |
| 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 BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer G1 | NATUS MANUFACTURING 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DANTEC CONCENTRIC NEEDLE ELECTRODE |
| Generic Name | DANTREC DISPOSABLE CONCENTRIC NEEDLE |
| Product Code | IKT |
| Date Received | 2018-03-16 |
| Model Number | 9013S0032 |
| Catalog Number | 9013S0032 |
| Lot Number | 44B/17/D |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-03-16 |