MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-02-14 for DANTEC CONCENTRIC NEEDLE ELECTRODE 9013S0012 manufactured by Natus Manufacturing Ltd..
[139466114]
Return of defective product has been requested. Work order (b)(4) was reviewed. No rework or sort performed on this lot. No excessive scrap quantities were noted. No ncr's related to this lot. Accepted run at risk 180 - related to retest of environmental monitoring of cleanroom. Pq135 noted - validation of concentric needles on andmar grinder (b)(4). Pq136 - protocol for visual inspection post electropolish. In process testing and inspections recorded on (b)(4) rev g were reviewed. All samples taken for tests gave acceptable results. The results for hub to cover retention test were within specification which is minimum 1. 2kgf. Lowest value recorded was 2. 145kgf, highest recorded value was 6. 630kgf. The following test was carried out previously for the same issue on a qty of 10 needles (retains): (ref (b)(4)). Hub to cover retention test- all needles passed with results within minimum spec of 1. 2kgf. Lowest value recorded was 1. 605kgf, highest recorded value was 5. 530kgf. (b)(4) risk management report for dantec dcn was reviewed. Potential hazard and hazardous situation identified associated with physical injury - needle stick, id 23 (needles are sharp, users could pierce themselves) and physical injury - cannula & hub assembly separates from outer colour cover id 29 (needle / hub sub-assembly may pull out of outer colour cover). The overall risk rating is 3a (low - green area) (severity of hazard - 3 - moderate, probability of hazard - a - unlikely). Capa (b)(4) has been opened to investigate this issue, status of this capa is at "implement actions". Justification for not providing below information and applicable sections: patient information - no patient injury reported, device malfunction occurred. Date of event: customer did not provide exact date that the incidents occurred but noted "(b)(6) 2018". Relevant tests / laboratory data - this section is not applicable as no patient injury occurred. Other relevant history, including preexisting medical conditions: this section is not applicable as no patient injury occurred. Suspect products - not applicable 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. Concomitant medical products and therapy dates (excluding treatment of event) - this section is not applicable to this type of device. 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.
Patient Sequence No: 1, Text Type: N, H10
[139466115]
Faulty part 9013s0012 lot 48a/17/d: separation of needles from the hub. "the base is disconnecting from the needle, making the assembly unusable. This defect occurred several times on lot 48a/17/d. (exp 27/11/2020). " customer noted this occurred on two needles of the same lot number and part number. (b)(4) (3005581270-2019-00004) is the reference number of the first incident and (b)(4) (3005581270-2019-00005) has been opened to document and report the second issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2019-00005 |
| MDR Report Key | 8339384 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-14 |
| Date of Report | 2019-04-11 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2017-11-27 |
| Date Added to Maude | 2019-02-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MISS LOUISE CALLANAN |
| Manufacturer Street | IDA BUSINESS 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 | DANTEC CONCENTRIC NEEDLE ELECTRODE |
| Generic Name | DANTEC DISPOSABLE CONCENTRIC NEEDLE |
| Product Code | IKT |
| Date Received | 2019-02-14 |
| Model Number | 9013S0012 |
| Catalog Number | 9013S0012 |
| Lot Number | 48A/17/D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LTD. |
| Manufacturer Address | IDA BUSINESS PARK GORT GALWAY,, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-14 |