MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	368589
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported with the use of the bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes there was clotting/micro clots/fibrin clots.The following information was provided by the initial reporter: the customer stated "the tubes are also clotting at the (b)(6) hospital.They have 2 lots of the pink-top tubes, one had no problems but the other clots.".
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for investigation.Therefore, 5 retention samples from bd inventory were evaluated for the quantity of edta additive that is present in the tube.All samples were within specification.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for clotting.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
Event or Problem Description
It was reported with the use of the bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes there was clotting/micro clots/fibrin clots.The following information was provided by the initial reporter: the customer stated "the tubes are also clotting at the (b)(6) hospital at (b)(6).They have 2 lots of the pink-top tubes, one had no problems but the other clots.".

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 10819918
• Report Number: 1917413-2020-01134
• Device Sequence Number: 11793188
• Product Code: JKA
• UDI-Device Identifier: 50382903685894
• UDI-Public: 50382903685894
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: BK980011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 368589
• Device Catalogue Number: 368589
• Device Lot Number: 0167257
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1