BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
Received Jan 29, 2026 · Event occurred Dec 10, 2025
Report 1917413-2026-00026 · MDR key 24211863
Device
Generic name
Blood/plasma Collection Device For Dna Testing
Manufacturer
Becton Dickinson & Co (franklin Lakes)Catalog number
362793
Lot number
5136435
Product problems
- Short Fill
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD RECEIVED 2 PHOTOS FOR INVESTIGATION. UPON VISUAL EVALUATION, THE PHOTOS SHOWED THE CUSTOMER¿S INDICATED FAILURE MODE. ADDITIONALLY, 100 RETAINED SAMPLES WERE VISUALLY INSPECTED WITH NO VISIBLE DEFECTS. FUNCTIONAL TESTS WERE PERFORMED ON 10 RETAINED SAMPLES, AND ALL TUBES WERE WITHIN SPECIFICATION LIMITS. 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: DRAW VOLUME. 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. 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 THAT WHEN USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, SIX (6) TUBES UNDERFILLED, REQUIRING RECOLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.