MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367899
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes, the device experienced underfill or low draw or a tube with blood.This event occurred 8 times.The following information was provided by the initial reporter.The customer stated: it was reported that tubes were only filling to 2ml thus resulting in underfilling.Kriz reported that the pink tubes on her cart were only filling about 2mls then stopping.She then tested a few with water and found that the two cases that were open were having the issue.So we tested new cases randomly from the same lot and they worked correctly.How many tubes have underfilled? we tested about 8 tubes and all for these two flats were underfilling.
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) 10.8mg blood collection tubes, the device experienced underfill or low draw or a tube with blood.This event occurred 8 times.The following information was provided by the initial reporter.The customer stated: it was reported that tubes were only filling to 2ml thus resulting in underfilling.Kriz reported that the pink tubes on her cart were only filling about 2mls then stopping.She then tested a few with water and found that the two cases that were open were having the issue.So we tested new cases randomly from the same lot and they worked correctly.How many tubes have underfilled? we tested about 8 tubes and all for these two flats were underfilling.
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: 11-may-2022.H.6.Investigation: 83 samples were returned from the customer in support of this complaint.All customer samples were visually inspected with no issues being identified.Separately, 10 customer sample tubes were functionally tested and the customer's indicated failure mode of underfill was not observed.Additionally, 10 production lot in-house retention tubes samples were functionally tested and no issues were observed as all 10 retention 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® K2 EDTA (K2E) 10.8MG 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: 14432033
• Report Number: 1917413-2022-00271
• Device Sequence Number: 15112050
• Product Code: JKA
• UDI-Device Identifier: 00382903678990
• UDI-Public: 00382903678990
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: BK980011
• 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): 05/23/2022

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: 03/31/2023
• Device Catalogue Number: 367899
• Device Lot Number: 1288714
• 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: 05/02/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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