MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367844
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
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 when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes it fail to fill the tube to the indicated line.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: ¿tubes do not exhaust the vacuum and fail to fill the tube to the indicated line and even others, it looks like they have no vacuum.¿.
Additional Manufacturer Narrative
H.6.Investigation: bd received 1 photo from the customer in support of this complaint.The photo shows the tube with no specimen in the tube, it is unknown if the tube was used from the photo.Therefore, 10 production lot in-house retention tubes from the bd inventory were visually inspected and 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 the customer¿s indicated failure mode as no samples were received, and the defect was not observed in the photo or the retention sample 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.The quantity of blood drawn into evaluated tubes varies with altitude, ambient temperature, barometric pressure, tube age, venous pressure, and filling technique.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes it fail to fill the tube to the indicated line.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: ¿tubes do not exhaust the vacuum and fail to fill the tube to the indicated line and even others, it looks like they have no vacuum.¿.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 12-jul-2022 h6: investigation summary bd received 2 samples and 1 photo from the customer in support of this complaint.The photo was evaluated and shows a tube with no specimen in the tube.It is unknown if the tube was used from the photo.The 2 sample tubes were functionally tested and the issue of underfill was not observed as all tubes were within specification limits.Additionally, 10 retention tubes from the bd inventory were functionally tested with no issues being observed.Bd was unable to confirm and/or duplicate the customer¿s indicated failure mode because the defect was not observed in the sample, photo, 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.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes it fail to fill the tube to the indicated line.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: ¿tubes do not exhaust the vacuum and fail to fill the tube to the indicated line and even others, it looks like they have no vacuum.¿.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 7.2MG 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
• 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: 14400686
• Report Number: 1917413-2022-00263
• Device Sequence Number: 5490001
• Product Code: JKA
• UDI-Device Identifier: 50382903678445
• UDI-Public: 50382903678445
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2022

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: 11/30/2022
• Device Model Number: 367844
• Device Catalogue Number: 367844
• Device Lot Number: 1195783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 05/25/2022; 07/19/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 05/27/2022; 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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