MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-28 for SAFESTEP HUBER NEEDLE LH-0031 manufactured by C. R. Bard, Inc. / Bd.
[122315911]
Rn went to dc port needle and safety did not engage, leaving needle exposed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080212 |
| MDR Report Key | 7922322 |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-09-19 |
| Date Added to Maude | 2018-10-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SAFESTEP HUBER NEEDLE |
| Generic Name | NON-CORING HUBER NEEDLE |
| Product Code | PTI |
| Date Received | 2018-09-28 |
| Model Number | LH-0031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C. R. BARD, INC. / BD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-28 |