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

Model Number	367842
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 3.6mg blood collection tube there was under-fill or low draw of a tube with blood the following information was provided by the initial reporter.The customer stated: "multiple pink top tubes are underfilling.".
Additional Manufacturer Narrative
Investigation summary: bd received 1030 samples and 1 photo from the customer in support of this complaint.The photo was evaluated and shows tubes in a shelf pack wrapped in shrinkwrap and does not show the customer¿s failure mode of underfill.1030 samples were inspected with no issues being identified.10 sample tubes were draw tested.All tubes were within specification limits.10 production lot in-house retention tubes samples were draw tested.All tubes were within specification limits.Bd was unable to confirm and/or duplicate the customer¿s indicated failure mode because the defect was not observed in the sample, photo, and retention testing.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15203884
• Report Number: 1917413-2022-00480
• Device Sequence Number: 4858798
• Product Code: JKA
• UDI-Device Identifier: 50382903678421
• UDI-Public: 50382903678421
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 07/20/2022

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: 09/30/2022
• Device Model Number: 367842
• Device Catalogue Number: 367842
• Device Lot Number: 1165622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown