BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
Received Mar 31, 2026 · Event occurred Mar 4, 2026
Report 1917413-2026-00201 · MDR key 24749066
Device
Generic name
Blood/plasma Collection Device For Dna Testing
Manufacturer
Becton Dickinson & Co (franklin Lakes)Catalog number
362788
Lot number
5169781
Product problems
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD RECEIVED 2 SAMPLES AND 2 PHOTOS FOR INVESTIGATION. THE IMAGES AND SAMPLES SHOW A WHITE SUBSTANCE IN THE GEL. 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 BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: FOREIGN MATTER-UNKNOWN. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. 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 TUBE K2E 9.0 MG, A FIBROUS WHITE FOREIGN MATTER WAS SEEN INSIDE OF TWO TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.