MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367842
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported during use the bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter: the customer stated "the tube that we recently started using does not ¿fill up¿ the way that other bd vacutainer tubes do.We even had two reports this past week that the tube, when used peripherally, stopped filling below the fill line and the blood in the butterfly needle started to ¿back up¿ into the patient.".
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer 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 non-conformances during manufacturing of the product.Bd has initiated further root cause investigation relating to the issue of underfill through a corrective and preventive action (capa#260774).H3 other text : see h.10.
Event or Problem Description
It was reported during use the bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter: the customer stated "the tube that we recently started using does not ¿fill up¿ the way that other bd vacutainer tubes do.We even had two reports this past week that the tube, when used peripherally, stopped filling below the fill line and the blood in the butterfly needle started to ¿back up¿ into the patient.".

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 3.6MG 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: 10667464
• Report Number: 1917413-2020-00924
• Device Sequence Number: 3174289
• Product Code: JKA
• UDI-Device Identifier: 50382903678421
• UDI-Public: 50382903678421
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K981013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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: 01/31/2021
• Device Model Number: 367842
• Device Catalogue Number: 367842
• Device Lot Number: 9280886
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other