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 2019-02-25 for TECA ELITE NEEDLE manufactured by Natus Manufacturing Ltd.
[141243493]
Justification for not providing below information: part a: patient information - no patient injury reported, device malfunction occurred. Date of event - date of event requested from the customer but information not yet provided. Relevant tests / laboratory data - not applicable as no patient injury occurred. Other relevant history, including preexisting medical conditions: this is not applicable as no patient injury occurred. Suspect products - not applicable. Model #, catalog #, lot#, expiration date, unique identifier - defect part number and lot number requested from the customer but information not yet provided. Serial # - this is not applicable as the medical device does not have a serial number. If implanted date (mm/dd/yyyy) - this is not applicable as the medical device is not implantable. If explanted date (mm/dd/yyyy) - this is not applicable as the medical device is not implantable. Reprocessor name and address - this 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 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 is not applicable as the medical device is not ind. Adverse event terms - this is not applicable to medical devices. Device manufacture date - awaiting device lot number to determine manufacture date if remedial action initiated, check type - this 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 is not applicable as there was no action reported under 21usc 360i(f).
Patient Sequence No: 1, Text Type: N, H10
[141243494]
Defective needles - hub to colour cover separation. The customer noted: "we have had 3 needles come detached from the plastic hub. While trying to take the needle off the cable holder, the plastic part comes away leaving the needle stuck in the cable holder with no cover. We had to use pliers to remove the needle from the hub. The needles used were teca concentric needles of varied sizes. " the customer has noted that there was 3 defect needles (incidents), the three incidents will be investigated under complaints: (b)(4) (ae no. 3005581270-2019-00003), (b)(4) (ae no. 3005581270-2019-00006), (b)(4) ((ae no. 3005581270-2019-00007).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2019-00007 |
| MDR Report Key | 8366074 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-25 |
| Date of Report | 2019-04-17 |
| Date Mfgr Received | 2019-02-08 |
| Date Added to Maude | 2019-02-25 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | TECA ELITE NEEDLE |
| Generic Name | TECA ELITE DISPOSABLE CONCENTRIC NEEDLE ELECTRODE,, |
| Product Code | IKT |
| Date Received | 2019-02-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-02-25 |