FDA Adverse Event
Injury
Summary report: N
1 MICRO FINE PLUS
MDR report key: 3142472
·
Received March 22, 2013
Report
- Report Number
- 2243072-2013-00014
- Event Type
- Injury
- Date Received
- March 22, 2013
- Date of Event
- February 20, 2013
- Report Date
- March 22, 2013
- Manufacturer
- BD
- Product Code
- FMI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED.
Description of Event or Problem · 1
ON (B)(6) 2013, THE NURSE GAVE AN INJECTION TO A PT WHO WAS HOSPITALIZED IN THE HEALTH CARE FACILITY FOR THE ELDERLY. DURING THE INJECTION TO THE ARM OF THE PT, THE NEEDLE BROKE AND REMAINED AT THE INJECTION SITE. PART OF THE BROKEN NEEDLE PROTRUDED FROM THE INJECTION SITE AND A DOCTOR WAS TRYING TO REMOVE THE BROKEN NEEDLE BY HAND, BUT FAILED AND THE DOCTOR LOST THE BROKEN NEEDLE. THE PT WAS THEN TRANSFERRED TO ANOTHER FACILITY AND THE NEEDLE WAS REMOVED SURGICALLY UNDER RADIOGRAPHIC GUIDANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121084 | 1 MICRO FINE PLUS | PEN NEEDLE 31G X 5MM | FMI | BD | 1278931B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Required Intervention |