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	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Date of event: unknown.The date received by manufacturer has been used.
Event or Problem Description
It was reported that 2 bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes underfilled.The following information was provided by the initial reporter: "material no.367899, batch no.0184376.It is reported customer experienced under filling.Verbiage received, - "product name: k2 edta 10.8 mg pink top tube/367899.Lot number: 0184376.Any injuries and/or harm: no.What is the issue you experienced: the vacuum did not work and the tubes were not able to be filled.This happened with two tubes.Is the actual sample available: yes.Contact name/phone number: (b)(6).".
Event or Problem Description
It was reported that 2 bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes underfilled.The following information was provided by the initial reporter: "material no.367899, batch no.0184376 it is reported customer experienced under filling.Verbiage received, - "product name: k2 edta 10.8 mg pink top tube/367899.Lot number: 0184376.Any injuries and/or harm: no.What is the issue you experienced: the vacuum did not work and the tubes were not able to be filled.This happened with two tubes.Is the actual sample available: yes.Contact name/phone number: (b)(6)"".
Additional Manufacturer Narrative
H6: 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) 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: 11121341
• Report Number: 1917413-2020-01287
• Device Sequence Number: 3701194
• Product Code: JKA
• UDI-Device Identifier: 50382903678995
• UDI-Public: 50382903678995
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: BK980011
• Number of Events Summarized: 1
• Summary Report (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): 01/25/2021

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: 367899
• Device Catalogue Number: 367899
• Device Lot Number: 0184376
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1