MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367859
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 5.4 mg blood collection tube there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: "something long protrude inside tube wall.The protrusion seemed like tube material and that effect the instrument.".
Additional Manufacturer Narrative
Investigation: bd received 2 photos from the customer in support of this complaint.An evaluation of the photos confirmed the presence of damage to the inside of the tube.No unused samples have been returned for evaluation.Nowhere on the production line is there anything introduced to the inside of the tube that would cause this type of defect.Additionally, 100 retention samples were visually inspected with no damage to the inside of the tube being identified and the customer's indicated failure mode of foreign matter was not observed.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.Bd was able to confirm the customer¿s indicated failure mode with the photos provided however, this defect is not caused by any process during the manufacturing of this product.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 5.4 mg blood collection tube there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: "something long protrude inside tube wall.The protrusion seemed like tube material and that effect the instrument.".
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 5.4 mg blood collection tube there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: "something long protrude inside tube wall.The protrusion seemed like tube material and that effect the instrument.".
Additional Manufacturer Narrative
The following fields have been updated to show the additional information provided.Imdrf: annex b grid:b01.H.6.Investigation summary:bd received 1 sample and 2 photos from the customer in support of this complaint.An evaluation of the sample and photos was conducted and confirmed the presence of damage to the inside of the tube, on the side wall the plastic has been peeled away from the inside wall of the tube.Additionally, 100 retention samples from the bd inventory were visually inspected with no damage to the inside of the tube being identified.The exact root cause of the failure mode cannot be determined.Bd was able to confirm the customer¿s indicated failure mode with the photos provided however, this defect is not caused by any process during the manufacturing of this product.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 5.4 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
• 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: 14342065
• Report Number: 1917413-2022-00246
• Device Sequence Number: 4860026
• Product Code: JKA
• UDI-Device Identifier: 50382903678599
• UDI-Public: 50382903678599
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2022

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: 02/28/2023
• Device Model Number: 367859
• Device Catalogue Number: 367859
• Device Lot Number: 1288698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 05/25/2022; 07/11/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 05/27/2022; 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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