MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-25 for CONCENTRIC NEEDLES manufactured by Natus Manufacturing Limited.
[109366895]
Justification for not providing below information and applicable sections: 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. Brand name - concentric needle but awaiting defect part number to establish the brand 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 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 occupation - information not provided by the customer. 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
[109366896]
Hub and cannula separation from colour cover during removal of connector cable. "manufacturer defect/safety concern: physician was removing a needle from the needle wire and it appears as though the needle is safely housed in the plastic sheath (as the coloured hub is attached to the plastic sheath) when in fact, the needle has dislodged from the coloured hub and is still on end of needle. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2018-00005 |
| MDR Report Key | 7543932 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-25 |
| Date of Report | 2018-05-25 |
| Date Mfgr Received | 2018-04-30 |
| Date Added to Maude | 2018-05-25 |
| 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 | NATUS MANUFACTURING LIMITED 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, 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 | CONCENTRIC NEEDLES |
| Generic Name | DISPOSABLE CONCENTRIC NEEDLE |
| Product Code | IKT |
| Date Received | 2018-05-25 |
| 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 | 2018-05-25 |