FDA Adverse Event
Malfunction
Summary report: N
OMNIFIX
MDR report key: 3111454
·
Received April 24, 2013
Report
- Report Number
- 9610825-2013-00101
- Event Type
- Malfunction
- Date Received
- April 24, 2013
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FOZ
- PMA / PMN Number
- K063280
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MFR). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(6) TO B BRAUN (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177784 | OMNIFIX | HYPODERMIC SYRINGE | FOZ | B. BRAUN MELSUNGEN AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |