BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E 15.8 MG
Received Jun 22, 2026 · Event occurred May 24, 2026
Report 1917413-2026-00556 · MDR key 25576884
Device
Generic name
Blood/plasma Collection Device For Dna Testing
Manufacturer
Becton Dickinson & Co (franklin Lakes)Catalog number
362799
Lot number
5197502
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: BROKEN/LEAKING. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E 15.8 MG, 1 TUBE LEAKED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.