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

Model Number	367899
Medical Device Problem Codes	Fluid/Blood Leak (1250); Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
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) 10.8mg blood collection tubes, the device experienced blood pulling in the stopper well, and underfill or low draw of a tube.The following information was provided by the initial reporter.The customer stated: describe the event or problem: when the nurse attempted to use a bd vacutamer® k2 edta (pink-top) tube to draw blood from the peripheral iv start, she noticed that the pxnk-top tube didn't seem to be filling up at the usual rate, and it didn't stay connected to the vacutainer very well.The nurse removed the pink-top lab draw tube, and noticed that blood began spilling from the top of the tube, around the area where the vacutainer inserts its needle into the lab tube.The patient's blood spilled on the sheets and on the nurse's scrubs, but did not touch any skin, so there was not any risk of blood exposure to non-intact skin.The nurse was able to find a second pink-top lab draw tube and obtain the necessary lab draw.The nurse saved the leaking pink-top lab draw tube so she could provide the lot number, and then later threw the lab draw tube in a biohazard container.No harm occurred and no additional pokes were ordered for the patient.This was just an equipment failure: the pink-top lab draw tubes usually do not leak blood around the caps.
Additional Manufacturer Narrative
H.6.Investigation: 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 or blood pooling 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 is unable to be confirmed for the indicated failure mode underfill and blood pooling.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes, the device experienced blood pulling in the stopper well, and underfill or low draw of a tube.The following information was provided by the initial reporter.The customer stated: describe the event or problem: when the nurse attempted to use a bd vacutamer® k2 edta (pink-top) tube to draw blood from the peripheral iv start, she noticed that the pxnk-top tube didn't seem to be filling up at the usual rate, and it didn't stay connected to the vacutainer very well.The nurse removed the pink-top lab draw tube, and noticed that blood began spilling from the top of the tube, around the area where the vacutainer inserts its needle into the lab tube.The patient's blood spilled on the sheets and on the nurse's scrubs, but did not touch any skin, so there was not any risk of blood exposure to non-intact skin.The nurse was able to find a second pink-top lab draw tube and obtain the necessary lab draw.The nurse saved the leaking pink-top lab draw tube so she could provide the lot number, and then later threw the lab draw tube in a biohazard container.No harm occurred and no additional pokes were ordered for the patient.This was just an equipment failure: the pink-top lab draw tubes usually do not leak blood around the caps.

• 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
• MDR Report Key: 12339822
• Report Number: 1917413-2021-00770
• Device Sequence Number: 11469545
• Product Code: JKA
• UDI-Device Identifier: 50382903678995
• UDI-Public: 50382903678995
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 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: 06/30/2022
• Device Model Number: 367899
• Device Catalogue Number: 367899
• Device Lot Number: 1014130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1