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 Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during decapping with bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes the rubber stopper remained in tube.There was no patient impact.The following information was provided by the initial reporter: customer reports that the automation line removes the pink plastic part of the cap but not the gray stopper.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 7 samples for investigation.The samples 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.The samples were subjected to functional testing and no issues were identified.Retention samples were visually inspected and subjected to functional testing, all were within the acceptable range for stopper shield separation.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 unable to replicate the reported defect through return and retention sample testing, this complaint is unconfirmed.Additionally, the ongoing investigation into customer closure separation (decapping) failures has made progress in the last few months.Based upon the a3 problem solving methods and kepner-tregoe tools for root cause analysis, two potential causes were identified and product has been manufactured under different experimental conditions to evaluate these potential causes.These product samples are being tested to verify key factors in production that may contribute to the separation of the stopper from the cap in automation lines feeding into tube analyzers.We also identified that our testing method required improvement to better reflect the dynamics and forces seen at the decapping step in tube automation lines.This method has been released and is being tested in parallel with historic methods to verify effectiveness in replicating the field failures.To date it has been able to better reflect the performance seen at our customer sites and we are moving to fully validate it for use on our design specifications in the future.Complaints received for this device and reported conditions will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
It was reported that during decapping with bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes the rubber stopper remained in tube.There was no patient impact.The following information was provided by the initial reporter: customer reports that the automation line removes the pink plastic part of the cap but not the gray stopper.

• 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
• 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 ; 8448235433
• MDR Report Key: 16892349
• Report Number: 1917413-2023-00400
• Device Sequence Number: 6838699
• Product Code: JKA
• UDI-Device Identifier: 50382903678995
• UDI-Public: (01)50382903678995
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 11/10/2023

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: 11/30/2023
• Device Model Number: 367899
• Device Catalogue Number: 367899
• Device Lot Number: 2166071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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