BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes
Received Jul 29, 2026 · Event occurred Jul 2, 2026
Report 1917413-2026-00669 · MDR key 50072929
Device
Generic name
Tubes, Vacuum Sample, With Anticoagulant
Manufacturer
Becton Dickinson & Co (franklin Lakes)Catalog number
367856
Lot number
Unknown
Product problems
- Improper Chemical Reaction
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported while using BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes, an unspecified number of tubes clotted. There was no health impact or consequences reported.
Additional Manufacturer Narrative
B3: Date of Event is unknown. The Date Received by Manufacturer has been used for this field.There were multiple 510K numbers reported to be involved. The information is as follows: G.4. PMA / 510(k)#: K213670;K231373.There were multiple Medical Device Types reported to be involved. The information for the additional device type is as follows: D2b. Medical Device Type: JKAD2a: Common Device Name: Tubes, vials, systems, serum separators, blood collectionD.4. Medical Device Expiration Date: UnknownH.4. Device Manufacture Date: Unknown.A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.