MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-28 for PROBLOC II REGIONAL BLOCK NEEDLE HN3S-80 manufactured by Halyard.
[96209443]
It is very hard to push fluid through the needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074306 |
| MDR Report Key | 7154575 |
| Date Received | 2017-12-28 |
| Date of Report | 2017-12-27 |
| Date of Event | 2017-12-27 |
| Date Added to Maude | 2017-12-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | PROBLOC II REGIONAL BLOCK NEEDLE |
| Generic Name | PROBLOC II REGIONAL BLOCK NEEDLE |
| Product Code | GXZ |
| Date Received | 2017-12-28 |
| Model Number | HN3S-80 |
| Lot Number | 0202791211 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD |
| Manufacturer Address | ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-28 |