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

Model Number	369714
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
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.
Event or Problem Description
It was reported the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes experienced stopper pops out of the tube.The event occurred twice.The following information was provided by the initial reporter.The customer stated: "the issue is that the top is coming off the blood vial vacutainer when the clinical staff is pulling it off from the vacutainer holder.We are only having this issue with the blue tops- none of the other blood tubes have had this issue.I have the blood tube from the last reported incident in a biohazard bag if bd needs it for review." additional information: 2/24/2021.Was there any blood exposure to the mouth or eye, if so please provide details.- no did any patients have to be redrawn, if so how many and on what dates?- yes, two was there any medical intervention, if so please provide details.- no do you have any unused samples available for the investigation?- have both a used sample in a biohazard bag and unused product that was pulled from the shelves.
Event or Problem Description
It was reported the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes experienced stopper pops out of the tube.The event occurred twice.The following information was provided by the initial reporter.The customer stated: "the issue is that the top is coming off the blood vial vacutainer when the clinical staff is pulling it off from the vacutainer holder.We are only having this issue with the blue tops- none of the other blood tubes have had this issue.I have the blood tube from the last reported incident in a biohazard bag if bd needs it for review." additional information: 2/24/2021 was there any blood exposure to the mouth or eye, if so please provide details.- no.Did any patients have to be redrawn, if so how many and on what dates?- yes, two.Was there any medical intervention, if so please provide details.- no.Do you have any unused samples available for the investigation?- have both a used sample in a biohazard bag and unused product that was pulled from the shelves.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 3/10/2021.H.6.Investigation: bd received 302 samples and no photos from the customer in support of this complaint.10 random samples were tested for stopper pop off and did not exhibit the customer¿s failure mode of ¿stopper pop off¿.Additionally, 10 retention samples were tested for stopper pop off and the tubes did not exhibit the customer¿s failure mode of ¿stopper pop off¿.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because the 10 samples were tested for stopper pop off and the tubes did not exhibit the customer¿s failure mode of ¿stopper pop off¿.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.H3 other text : see h.10.

• 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: 11455022
• Report Number: 1917413-2021-00175
• Device Sequence Number: 4048996
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• 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,Followup
• Report Date (Section B): 03/30/2021

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: 03/31/2022
• Device Model Number: 369714
• Device Catalogue Number: 369714
• Device Lot Number: 0258368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1