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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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, the device experienced poor barrier separation of the sample.The following information was provided by the initial reporter.The customer stated: customer stated that they are experiencing platelet clumping in the lavender and blue top tubes and they aren't sure why.They have had to redraw every patients blood that the clumping has happened.It is the same person collecting the patients that there is an issue with.Some will have an elevated wbc and slides are made and the platelet clumps are verified.These patients are from a primary care practice.Tubes are transported by courier and arrive same day usually within 4-6 hours of collection.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for evaluation.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.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, the device experienced poor barrier separation of the sample.The following information was provided by the initial reporter.The customer stated: customer stated that they are experiencing platelet clumping in the lavender and blue top tubes and they aren't sure why.They have had to redraw every patients blood that the clumping has happened.It is the same person collecting the patients that there is an issue with.Some will have an elevated wbc and slides are made and the platelet clumps are verified.These patients are from a primary care practice.Tubes are transported by courier and arrive same day usually within 4-6 hours of collection.

• 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: 11940861
• Report Number: 1917413-2021-00487
• Device Sequence Number: 17133422
• 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): 06/23/2021

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: 02/28/2022
• Device Model Number: 367844
• Device Catalogue Number: 367844
• Device Lot Number: 0289404
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1