MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	368589
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
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 that prior to use with a bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes the tubes were discovered to be missing additive.The following information was provided by the initial reporter: it was reported that the tubes are missing gel or powder.
Event or Problem Description
It was reported that prior to use with a bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes the tubes were discovered to be missing additive.The following information was provided by the initial reporter: it was reported that the tubes are missing gel or powder.
Additional Manufacturer Narrative
Investigation: bd had not received samples or photos for evaluation.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.H3 other text : see h.10.

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 18 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: 10786995
• Report Number: 1917413-2020-01114
• Device Sequence Number: 11503147
• Product Code: JKA
• UDI-Device Identifier: 50382903685894
• UDI-Public: 50382903685894
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/02/2020

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: 06/30/2022
• Device Model Number: 368589
• Device Catalogue Number: 368589
• Device Lot Number: 0167257
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1