FDA Adverse Event
Malfunction
Summary report: N
LUER LOCK
MDR report key: 303927
·
Received November 7, 2000
Report
- Report Number
- 303927
- Event Type
- Malfunction
- Date Received
- November 7, 2000
- Date of Event
- October 30, 2000
- Report Date
- November 7, 2000
- Manufacturer
- BECTON DICKINSON & CO
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ADD'L INFO REC'D FROM MFR 1/18/01: THE BLUNT PLASTIC CANNULA IS NOT APPROVED FOR PRACTICE WHEN TRYING TO ACCESS A SITE THAT IS NOT PRE-PIERCED. THE REASONS ARE THAT THE BLUNT PLASTIC CANNULA CENTERPOINT DOES NOT HAVE A CUTTING POINT AND THEREFORE IS NOT DESIGNED TO BE PUSHED THROUGH A SOLID RUBBER IV PORT (SEPTUM). THE BPC APPROVED PRACTICE IS FOR USE IN SUCH ACCESS SITES AS BAXTER INJECTION SITE OR ABBOTT LIFESHIELD SEPTUM. MFG WILL BE ADVISED OF THIS REPORT.
Description of Event or Problem · 1
WHEN ATTEMPTING TO PUSH SYRINGE TIP INTO HEPLOCK OF NEEDLESS SYSTEM, TIP OF SYRINGE BENDS BUT WILL NOT PENETRATE NEEDLESS SYSTEM. THIS ONLY HAPPENS WITH THESE HARD TIPPED CLEAR TIPS, NOT THE OTHERS. THIS HAS HAPPENED TO REPORTER BEFORE WITH THIS TYPE OF CANNULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUER LOCK | B-D 5CC SYRINGE WITH BLUNT PLASTIC CANNULA | FMF | BECTON DICKINSON & CO | 303347/DG64200 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other | BAXTER INTERLINK AT SYSTEM (2N3378),| WITH RETRACTABLE COLLAR.| I.V CATHETER EXTENSION SET, |