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 Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: bd did not receive samples or photographs from the customer in support of this complaint.Therefore, 20 retained samples were functionally tested and the customer's indicated failure mode for underfill was not observed as all 20 tubes drew within specification.Bd was unable to confirm customers indicated failure mode based on the 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 under-fill or low draw of a tube with blood.This event was reported to occur 2000 times.The customer states they had to "destroy 2500 unused tubes." the following information was provided by the initial reporter and translated to english.The customer stated: "the reagent in the tube no longer works." additional information received: the customer stated: "our laboratory informed us that they had received tubes that were not filled correctly, we tried several times with tubes from the same batch and found the same anomaly, the tubes could not be analyzed.".

• 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: 12682417
• Report Number: 9617032-2021-01087
• Device Sequence Number: 3855704
• Product Code: JKA
• UDI-Device Identifier: 50382903630474
• UDI-Public: 50382903630474
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/30/2021

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: 09/30/2021
• Device Model Number: 363047
• Device Catalogue Number: 363047
• Device Lot Number: 1085026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1