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

Model Number	367859
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	03/03/2021
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) 5.4 mg blood collection tubes there was under-fill or low draw of a tube with blood.This event occurred 20 times.The following information was provided by the initial reporter.The customer stated: there was "vacuum loss and low volume draw.".
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 5.4 mg blood collection tubes there was under-fill or low draw of a tube with blood.This event occurred 20 times.The following information was provided by the initial reporter.The customer stated: there was "vacuum loss and low volume draw.".
Additional Manufacturer Narrative
Investigation summary bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by draw 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 not able to identifiy a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 5.4 MG 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: 11572100
• Report Number: 1917413-2021-00229
• Device Sequence Number: 4266777
• Product Code: JKA
• UDI-Device Identifier: 50382903678599
• UDI-Public: 50382903678599
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/20/2021

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: 12/31/2021
• Device Model Number: 367859
• Device Catalogue Number: 367859
• Device Lot Number: 0227220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1