MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-03 for DANTEC CONCENTRIC NEEDLE manufactured by Natus Manufacturing Limited.
[116072979]
Defect parts requested to be returned. Part number and lot number requested. Justification for not providing below information and applicable sections: 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 - this section is not applicable as no patient injury occurred. Brand name - dantec needle part - awaiting defect part number to establish the brand name - requested from the customer but information not yet provided. Common device name - dantec needle part - awaiting defect part number to establish common device name - requested from the customer but information not yet provided. Model #, catalog #, lot#, expiration date, unique identifier - defect part number and lot number requested from the customer but information not yet provided. 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. Pms/510(k) - device number requested from the customer but information not yet provided. Device manufacture date - awaiting device lot number to determine manufacture date. 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
[116072980]
The needle remains blocked after use. Removable with a clip with the risk of pricking. On reviewing, the piture provided to natus from the customer, this appears to be a hub and cannula separation from the colour cover.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2018-00008 |
| MDR Report Key | 7746134 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-03 |
| Date of Report | 2018-09-27 |
| Date Mfgr Received | 2018-07-11 |
| Date Added to Maude | 2018-08-03 |
| 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 | MISS 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 | NATUS MANUFACTURING LIMITED IDA BUSINESS PARK |
| Manufacturer City | GORT, 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 |
| Generic Name | DISPOSABLE CONCENTRIC NEEDLE |
| Product Code | IKT |
| Date Received | 2018-08-03 |
| 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 LIMITED |
| Manufacturer Address | IDA BUSINESS PARK GORT GALWAY, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-03 |