MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-21 for BARD SAFESTEP HUBER NEEDLE manufactured by Bard Access Systems, Inc. / Bd.
[121707923]
The access device was acting difficult to remove from the port. Device did not appear to be broken in anyway. The needle pulled completely out of device and the safety cover did not engage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080066 |
| MDR Report Key | 7901909 |
| Date Received | 2018-09-21 |
| Date of Report | 2018-09-20 |
| Date of Event | 2018-06-25 |
| Date Added to Maude | 2018-09-24 |
| 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 | BARD SAFESTEP HUBER NEEDLE |
| Generic Name | NON-CORING (HUBER) NEEDLE |
| Product Code | PTI |
| Date Received | 2018-09-21 |
| Lot Number | ASCRS0130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS, INC. / BD |
| Manufacturer Address | SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-21 |