INTROCAN SAFETY® 2
Received Jul 29, 2026
Report 9610825-2026-00384 · MDR key 50068787
Device
Generic name
Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Manufacturer
B. Braun Melsungen AgCatalog number
4242012-02
Lot number
25N01G8B04
Product problems
- Difficult to Remove
- Mechanics Altered
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
As reported by the user facility:Issue: the IV catheters are getting stuck when removing the needle, and in one instance, the entire one-way valve came out while withdrawing the needle. The defective products have been disposed of in a sharps container, but a photo taken prior to disposal was attached.
Additional Manufacturer Narrative
This report has been identified as B. Braun Medical internal report number (b)(4).Batch Manufacturing Record (BMR):Reviewed in SAP MYA the BMR of batch 25N01G8B04, no similar defect was recorded during In-Process and at Final Control product inspection.Evidence at Disposal:No sample was received; however, two pictures were provided.Picture 1: a used INTROCAN SAFETY 2 WL PUR 18G with the septum opener had detached and covering the tip of the cannula/steel needle.Picture 2: a peel packaging for lot 25N01G8B04 and material number 4242012-02 INTROCAN SAFETY 2 WL PUR 18GX32MM - US.Septum opener detached is a known defect. Complaint is confirmed. An approved project is in place to further address issues with detachment. We will maintain this report for further references and continue to monitor other reports for similar occurrences. If any additional pertinent information becomes available, a follow up will be submitted.