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

Model Number	367899
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
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.
Event or Problem Description
It was reported while using bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes are exploding and the tops are crooked.The issue occurred 3 times.The following information was provided by the initial reporter: customer problem: customer is reporting tubes exploding on product 367899, lot 2048419.Steps taken with customer/troubleshooting: customer is reporting multiple tubes explode in the tube system, and birth center had one explode while drawing it in the patient's room.Customer stated that upon further examination of the tubes, they found that the caps are crooked.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 2022-09-30.H.6.Investigation summary: bd received 600 samples from the customer in support of this complaint.The samples were inspected with no issues being identified.Additionally, 10 customer samples were functionally tested and there were no issues related to the hemogard closure assembly, being loose or separating during or after the testing was completed.Furthermore, 100 retention samples from the bd inventory from both lots were visually inspected with the hemogard closure assembly correctly assembled and placed on the tubes.There were no cocked stoppers identified that would cause the hemogard closure assembly to not be applied correctly.10 retention samples were functionally tested and no issues with the hemogard closure assembly being loose or separating during or after the draw testing were observed.Bd was unable to confirm the customer¿s indicated failure mode with the samples that were returned, and the failure mode could not be seen in the photo as the closure was not the manufactured closure and could not be duplicated in the retention sample 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.The instructions for use state that reinsertion of the hemogard closure is to replace closure over tube, twist and push down firmly until stopper is fully reseated.Complete reinsertion of the stopper is necessary for the closure to remain securely on the tube during handling.H3 other text : see h.10.
Event or Problem Description
It was reported while using bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes are exploding and the tops are crooked.The issue occurred 3 times.The following information was provided by the initial reporter: customer problem: customer is reporting tubes exploding on product 367899, lot 2048419.Steps taken with customer/troubleshooting: customer is reporting multiple tubes explode in the tube system, and birth center had one explode while drawing it in the patient's room.Customer stated that upon further examination of the tubes, they found that the caps are crooked.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 10.8M
• 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: 15403171
• Report Number: 1917413-2022-00541
• Device Sequence Number: 5056380
• Product Code: JKA
• UDI-Device Identifier: 50382903678995
• UDI-Public: 50382903678995
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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: 07/31/2023
• Device Model Number: 367899
• Device Catalogue Number: 367899
• Device Lot Number: 2048419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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