FDA Adverse Event
Other
Summary report: N
INTROCAN SAFETY
MDR report key: 3011221
·
Received March 15, 2013
Report
- Report Number
- 9610825-2013-00060
- Event Type
- Other
- Date Received
- March 15, 2013
- Report Date
- February 22, 2013
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FOZ
- PMA / PMN Number
- K982805
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4). NO SAMPLE HAS BEEN RETURNED FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE STATEMENT FROM THE MANUFACTURER IS AVAILABLE.
Description of Event or Problem · 1
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): THE CLIP WAS NOT WELL POSITIONED ON THE TIP OF THE NEEDLE. NEEDLE STICK INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110893 | INTROCAN SAFETY | I.V. SAFETY CATHETER | FOZ | B. BRAUN MELSUNGEN AG | NA | 3A11258316 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |