InjuryPTI
SURECAN SAFETY II
Received Jun 10, 2026 · Event occurred May 2, 2026
Report 9612452-2026-00029 · MDR key 25459475
Device
Generic name
Needle For Access Port
Manufacturer
B.braun Medical SasModel number
4447005Lot number
25E11G8671
Product problems
- Fail-Safe Did Not Operate
Patient
NA · Unknown
- Needle Stick/Puncture
Narrative
Additional Manufacturer Narrative
NOTE: PRODUCT REFERENCE 4447005 IS NOT CLEARED FOR SALES IN THE USA, BUT IT IS SIMILAR TO THE PRODUCT REFERENCE CLEARED UNDER #510K170897. INVESTIGATION RESULTS WILL BE SENT IN THE MEDWATCH REPORT FOLLOW-UP.
Description of Event or Problem
AFTER A BLOOD SAMPLE WAS TAKEN THROUGH A PORT, THE SAFETY LOCK JAMMED AND DID NOT CLOSE PROPERLY, CAUSING THE HEALTHCARE WORKER TO ACCIDENTALLY PRICK HIMSELF.