MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367844
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
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.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes experienced clotting/micro clots/fibrin clots.The following information was provided by the initial reporter.The customer stated: (3 of 4) win it was reported there was platelet clumps.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for evaluation.Therefore, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to platelet clumping were observed.The samples were visually inspected for the presence of edta additive, all tubes were found to contain edta spray coating on the inner walls of the tube.Following visual inspection, samples were tested for the quantity of the edta additive that is present in the tube and all samples were within specification requirements.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure (erroneous results/platelet clumping) because the defect was not evident in the testing of the complaint lot (retention) samples.Replicates of both complaint and control samples tested were acceptable in terms of both precision and accuracy.Laboratory visual evaluations of retain samples indicated that the edta tubes performed as expected.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 was unable to be confirmed with respect to platelet clumping.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes experienced clotting/micro clots/fibrin clots.The following information was provided by the initial reporter.The customer stated: (3 of 4) win: it was reported there was platelet clumps.

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 7.2MG 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: 11867342
• Report Number: 1917413-2021-00421
• Device Sequence Number: 16937154
• Product Code: JKA
• UDI-Device Identifier: 50382903678445
• UDI-Public: 50382903678445
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• 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): 06/15/2021

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: 04/30/2022
• Device Model Number: 367844
• Device Catalogue Number: 367844
• Device Lot Number: 0345756
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1