FDA Adverse Event
Malfunction
Summary report: N
PILLING HEPARIN CANNULA 1.5MM TIP 2 1/8"
MDR report key: 2180801
·
Received April 29, 2011
Report
- Report Number
- 1044475-2011-00047
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- March 31, 2011
- Report Date
- April 4, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- DWF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE IS AVAILABLE FOR INVESTIGATION. INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: SHAFT CAME OUT OF THE LUER LOCK CONNECTION DURING A PROCEDURE. NO REPORTED PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PILLING HEPARIN CANNULA 1.5MM TIP 2 1/8" | HEPARIN CANNULA | DWF | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |