MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-15 for INJETAK ADJUSTABLE TIP NEEDLE DIS199 manufactured by Laborie Medical Technologies.
[102833543]
While using a laborie injetak adjustable tip needle, the needle was not coming out of the catheter far enough.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075901 |
| MDR Report Key | 7344658 |
| Date Received | 2018-03-15 |
| Date of Report | 2018-03-14 |
| Date of Event | 2018-03-14 |
| Date Added to Maude | 2018-03-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INJETAK ADJUSTABLE TIP NEEDLE |
| Generic Name | NEEDLE TIP CATHETER |
| Product Code | FBK |
| Date Received | 2018-03-15 |
| Model Number | DIS199 |
| Catalog Number | DIS199 |
| Lot Number | D168088 |
| Device Expiration Date | 2019-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LABORIE MEDICAL TECHNOLOGIES |
| Manufacturer Address | WILLISTON VT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-15 |