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	05/28/2021
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, the device experienced clotting/micro clots/fibrin clots.The following information was provided by the initial reporter.The customer stated: it was reported that there is clumping.Yes, the specimen was filled to the proper draw volume and inverted 8-10 times.We had been storing the tubes in the refrigerator after drawing.We are no longer doing that.They stay at room temp until testing.The lot numbers i originally reported were accidentally all disposed of.There has been clumping in lot #1014079 lavender edta as well.I do have some of these tubes.
Additional Manufacturer Narrative
H6: investigation summary bd received 7 samples for investigation, however retention samples (of the same lot) were used for testing.Retention samples were selected from bd inventory and further evaluated and no issues relating to platelet clumping were observed.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 (sample quality/platelet clumping) because the defect was not evident in the testing of the complaint lot samples.Laboratory analysis of retain and control samples demonstrated clinically acceptable performance for all visual observations evaluated.In addition, a visual review of retention samples was performed, with no issues being identified.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 platelet clumping.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes, the device experienced clotting/micro clots/fibrin clots.The following information was provided by the initial reporter.The customer stated: it was reported that there is clumping.Yes, the specimen was filled to the proper draw volume and inverted 8-10 times.We had been storing the tubes in the refrigerator after drawing.We are no longer doing that.They stay at room temp until testing.The lot numbers i originally reported were accidentally all disposed of.There has been clumping in lot #1014079 lavender edta as well.I do have some of these tubes.

• 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: 12037736
• Report Number: 1917413-2021-00530
• Device Sequence Number: 4000136
• 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): 08/02/2021

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: 05/31/2022
• Device Model Number: 367844
• Device Catalogue Number: 367844
• Device Lot Number: 1014079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1