MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	366560
Medical Device Problem Code	Overfill (2404)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Date of event: unknown.The date received by manufacturer has been used for this field.Device manufacture date: unknown.Investigation summary: bd had not received samples or photos from your facility for evaluation.Additionally, we were unable to determine the specific lot number associated with this complaint.Therefore, a review of the manufacturing records could not be conducted.Bd is continually monitoring complaints received for this device and reported condition in order to identify emerging trends.
Event or Problem Description
It was reported the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes experienced overfill.The following information was provided by the initial reporter.The customer stated: "customer is having issues with the tubes over filling and the instrument (acl top 550) is now showing an error message.I spoke with the customer on (b)(6) 2021 - customer stated that she has seen overfill, but it was a bd correction report that prompted her to call bd to see if there was any other tubes that can be ordered that do not have to overfill issue.".

• Brand Name: BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) 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: 11717537
• Report Number: 1917413-2021-00314
• Device Sequence Number: 4219734
• Product Code: JKA
• UDI-Device Identifier: 50382903665605
• UDI-Public: 50382903665605
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

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: 366560
• Device Catalogue Number: 366560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1