MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367835
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd received 3 photos from the customer in support of this complaint.The photos were visually evaluated showing the amount of specimen drawn into the tubes is below the fill line on the tube label.As no customer samples were received at the manufacturing site, the investigation was limited.Additionally, 10 retention samples from the bd inventory were 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 able to confirm the customer¿s indicated failure mode with the photos provided; however, no samples were returned to be tested and the complaint could not be duplicated in the retention testing.The exact cause for the customer¿s failure mode could not be determined.The device history records were reviewed on both lots 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.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes, the device experienced underfill or low draw of a tube with blood.This event occurred two times.The following information was provided by the initial reporter.The customer stated: tubes have vacuum deficiency.
Additional Manufacturer Narrative
H6: investigation summary bd received 3 photos from the customer in support of this complaint.The photos were visually evaluated showing the amount of specimen drawn into the tubes is below the fill line on the tube label.As no customer samples were received, the investigation was limited.Additionally, 10 retention samples from the bd inventory were 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 able to confirm the customer¿s indicated failure mode of underfill with the photos provided; however, no samples were returned to be tested and the complaint could not be duplicated in the retention testing.The exact cause for the customer¿s failure mode could not be determined.The device history records were reviewed on both lots 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) 5.4mg blood collection tubes, the device experienced underfill or low draw of a tube with blood.This event occurred two times.The following information was provided by the initial reporter.The customer stated: tubes have vacuum deficiency.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-08-31.H6: investigation summary: bd received 5 samples and 3 photos for investigation.The photos were visually evaluated showing the amount of specimen drawn into the tubes is below the fill line on the tube label.Additionally, the customer samples along with 10 retention samples from bd inventory, were evaluated by functional testing and no issues were observed relating to underfill as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Bd was able to confirm the customer¿s indicated failure mode with the photos provided; however, the complaint could not be duplicated in the returned samples or the retention testing.Bd was not able to identify a root cause for the indicated failure mode.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) 5.4mg blood collection tubes, the device experienced underfill or low draw of a tube with blood.This event occurred two times.The following information was provided by the initial reporter.The customer stated: tubes have vacuum deficiency.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 5.4MG 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: 14646849
• Report Number: 1917413-2022-00311
• Device Sequence Number: 17572803
• Product Code: JKA
• UDI-Device Identifier: 00382903678358
• UDI-Public: 00382903678358
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2022

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 Catalogue Number: 367835
• Device Lot Number: 1195777
• 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: 05/18/2022
• Supplement Date Received by Manufacturer: 07/15/2022; 09/21/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 08/10/2022; 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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: Male