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

Catalog Number	366560
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	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes, the device experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: it was reported that once in the vein, blood begins to flow but stops abruptly.We are currently using your 2.7 ml sodium citrate for our nih-funded clinical trial, ignite.We've had significant issues recently collecting blood in these tubes specifically.Once in the vein, blood begins to flow but stops abruptly.At times we have tried up to 8 different tubes within a pack and rarely get one that works.All of bd tubes work seamlessly with the same stick, so we believe there is an issue with the tube.
Event or Problem Description
It was reported when using the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes, the device experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: it was reported that once in the vein, blood begins to flow but stops abruptly.We are currently using your 2.7 ml sodium citrate for our nih-funded clinical trial, ignite.We've had significant issues recently collecting blood in these tubes specifically.Once in the vein, blood begins to flow but stops abruptly.At times we have tried up to 8 different tubes within a pack and rarely get one that works.All of bd tubes work seamlessly with the same stick, so we believe there is an issue with the tube.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/20/2021.H.6.Investigation: bd received 3 samples from the customer in support of this complaint.The 3 sample tubes, along with 10 retention samples of the bd inventory, were functionally tested and the customer's indicated failure mode of underfill was not observed as all tubes were within specification limits.Bd was unable to confirm and/or duplicate the customer¿s indicated failure mode because the defect was not observed in the sample and retention testing.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 TUBE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13159935
• Report Number: 1917413-2021-01100
• Device Sequence Number: 3978805
• Product Code: JKA
• UDI-Device Identifier: 00382903665600
• UDI-Public: 00382903665600
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 01/05/2022

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: 05/31/2022
• Device Catalogue Number: 366560
• Device Lot Number: 1228002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown