MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-21 for ENOXAPARIN PRE-FILLED SYRINGE 63323-0568-94 manufactured by Sanofi - Aventis.
[83295401]
Nurse administered enoxaparin 30mg injection to pt and syringe safety device did not engage. Needle and plunger came out of the device and was found in the pt's bed. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071700 |
| MDR Report Key | 6806786 |
| Date Received | 2017-08-21 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-08-15 |
| Date Added to Maude | 2017-08-21 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | ENOXAPARIN PRE-FILLED SYRINGE |
| Generic Name | SYRINGE, ANTISTICK |
| Product Code | MEG |
| Date Received | 2017-08-21 |
| Catalog Number | 63323-0568-94 |
| Lot Number | 6L0NLA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SANOFI - AVENTIS |
| Manufacturer Address | LAKE ZURICH 60047 60047 |
| Brand Name | HEPARIN LOCK FLUSH |
| Generic Name | HEPARIN, VASCULAR ACCESS FLUSH |
| Product Code | NZW |
| Date Received | 2017-08-21 |
| Catalog Number | 63323-0568-94 |
| Lot Number | 6L0NLA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS - KABI (NOVAPLUS) |
| Manufacturer Address | LAKE ZURICH 60047 60047 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-21 |