MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	363047
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	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd received one photograph from the customer in support of this complaint.The photo demonstrates some kind of foreign matter presented on a white bandage and a tube is not present.Therefore, 100 retained samples were visually checked and no defects were found.Bd was unable to duplicate or confirm the customer¿s indicated failure mode based on the photograph attached and retained samples test results.No definitive root cause could be established for the reported defect.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.
Event or Problem Description
It was reported when using the bd vacutainer® 9nc 0.109m buffered trisodium citrate plus blood collection tube 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 was "foreign matter in the tube.".

• Brand Name: BD VACUTAINER BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 12475777
• Report Number: 9617032-2021-00950
• Device Sequence Number: 11747250
• Product Code: JKA
• UDI-Device Identifier: 50382903630474
• UDI-Public: 50382903630474
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K013971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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: 12/31/2021
• Device Model Number: 363047
• Device Catalogue Number: 363047
• Device Lot Number: 1179653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1