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 Code	No Patient Involvement (2645)
Date of Event	10/14/2020
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 experienced clotting/micro clots/fibrin clots.The following information was provided by the initial reporter: the customer stated "tubes are used for automated blood bank, but we have been having problems with this lot number clotting.The tubes are labeled correctly as k2 edta but the liquid in the tube is incorrect.I believe it is clot activator instead of anticoagulant.".
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for the investigation.5 in-house retains were tested and the customer¿s indicated failure mode of ¿clotting¿ with the incident lot was not observed in the retention samples.Titration was performed and all tubes passed.All retention samples were within specifications.In addition retains were visually inspected with no issues being identified.All tubes met specification requirements.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 unable to duplicate or confirm the customer¿s indicated failure mode with the retention samples bd was not able to identify a root cause for the indicated failure modes.
Event or Problem Description
It was reported with the use of the bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes experienced clotting/micro clots/fibrin clots.The following information was provided by the initial reporter: the customer stated "tubes are used for automated blood bank, but we have been having problems with this lot number clotting.The tubes are labeled correctly as k2 edta but the liquid in the tube is incorrect.I believe it is clot activator instead of anticoagulant.".

• 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: 10782258
• Report Number: 1917413-2020-01052
• Device Sequence Number: 3630236
• 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
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: 10/14/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1