MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367899
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0316377, medical device expiration date: 2022-04-30, device manufacture date: 2020-11-11.Medical device lot #: 1014130, medical device expiration date: 2022-06-30, device manufacture date: 2021-01-14.Investigation summary: bd received 5 samples from lot 0316377 and 5 samples from lot 1014130 for investigation.The samples were evaluated by visual examination and the indicated failure mode for contamination with the incident lot was not observed as all product specifications were met.The product contains a k2 edta additive and there is no foreign material in the tubes that could be seen visually with the naked eye.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) 10.8mg blood collection tubes there was foreign matter in the tube(s) biological and non-biological the following information was provided by the initial reporter.The customer stated: "there is contamination in the tubes.Customer is seeing the contamination under the microscope.Patients didn't have to be redrawn.".

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 10.8MG 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: 12079626
• Report Number: 1917413-2021-00546
• Device Sequence Number: 4987586
• Product Code: JKA
• UDI-Device Identifier: 50382903678995
• UDI-Public: 50382903678995
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: BK980011
• 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
• Report Date (Section B): 06/09/2021

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 Model Number: 367899
• Device Catalogue Number: 367899
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1