MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-01-04 for BD ECLIPSE 305760 manufactured by Bd.
[16736094]
Nurse at a clinic drew up a dose of flu vaccine with one eclipse needle, removed and discarded the needle. She then attached another eclipse needle and administered the flu vaccination to an adult pt. After the injection she reported that the needle/syringe was in her right hand, she used the middle finger on her left hand to activate the safety shield and the shield broke off causing her to injure her left middle finger. She described that as she activated the safety shield it completely fell off exposing her to the contaminated needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041187-2011-00001 |
| MDR Report Key | 1952450 |
| Report Source | 05,06 |
| Date Received | 2011-01-04 |
| Date of Report | 2010-12-04 |
| Date of Event | 2010-12-02 |
| Date Mfgr Received | 2010-12-06 |
| Date Added to Maude | 2011-06-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL PASINO |
| Manufacturer Street | 1 BECTON DR |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal | 07417 |
| Manufacturer Phone | 2018474269 |
| Manufacturer G1 | BD |
| Manufacturer Street | 30 TUAS AVENUE 2 |
| Manufacturer City | SINGAPORE 639641 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 639641 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD ECLIPSE |
| Generic Name | 23G X 1" SHIELDING HYPODERMIC NEEDLE |
| Product Code | LLL |
| Date Received | 2011-01-04 |
| Model Number | NA |
| Catalog Number | 305760 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Manufacturer Address | 30 TUAS AVENUE 2 SINGAPORE SN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-04 |