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

Model Number	367835
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	07/28/2021
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 when using the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tube there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: the "tube doesn't fill properly.".
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples, but 1 photo and one video were provided for investigation.The photo and video was reviewed and the indicated failure mode for underfill was observed.The quantity of blood drawn into evaluated tubes varies with altitude, ambient temperature, barometric pressure, tube age, venous pressure, and filling technique.Additionally, 10 retention samples from bd inventory were evaluated by draw testing and the issue of underfill was not observed 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.This complaint has been confirmed for the indicated failure mode underfill.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
Event or Problem Description
Tube doesn't fill properly.Information received on 08/10/2021: there was no damage.No inconsistent results related to the failure have been released.

• 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
• MDR Report Key: 12328245
• Report Number: 1917413-2021-00743
• Device Sequence Number: 4542901
• Product Code: JKA
• UDI-Device Identifier: 50382903678353
• UDI-Public: 50382903678353
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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: 08/31/2021
• Device Model Number: 367835
• Device Catalogue Number: 367835
• Device Lot Number: 0100251
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1