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 Consequences Or Impact To Patient (2199)
Date of Event	09/09/2020
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 that after use with a bd vacutainer® edta (k2e) 18 mg blood collection tubes the samples were clotted.This occurred with several patient samples, however, patient information is unknown.Some patients had a delay in results others required additional needle sticks.The following information was provided by the initial reporter: it was reported that samples were clotted.
Additional Manufacturer Narrative
H.6.Investigation: bd ids received no samples from the customer facility for investigation at the manufacturing site.No photos were received.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.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Bd was unable to confirm the customer¿s indicated failure mode.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported that after use with a bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes the samples were clotted.This occurred with several patient samples, however, patient information is unknown.Some patients had a delay in results others required additional needle sticks.The following information was provided by the initial reporter: it was reported that samples were clotted.

• 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: 10608248
• Report Number: 1917413-2020-00892
• Device Sequence Number: 437449
• Product Code: JKA
• UDI-Device Identifier: 50382903685894
• UDI-Public: 50382903685894
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/07/2020

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: 09/10/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other