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 Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
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) 10.8mg blood collection tube the rubber stopper remained in tube (stopper/shield separation).The following information was provided by the initial reporter.The customer stated: "the stopper is not being removed by the analyzer.".
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 10.8mg blood collection tube the rubber stopper remained in tube (stopper/shield separation).The following information was provided by the initial reporter.The customer stated: "the stopper is not being removed by the analyzer.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd did not receive samples, but one (1) photograph was returned for investigation.The photo was visually examined and the indicated failure mode for closure separation was not observed.The photo showed a shelf pack for batch verification.Ten (10) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to closure separation as all samples met specifications.One hundred (100) retains were visually examined, and no issues were observed.Additionally, twenty (20) retained samples were sent to franklin lakes for further functional testing by r&d.R&d retain sample testing was satisfactory.Bd was unable to duplicate or confirm the customer¿s indicated failure mode.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.Additionally, the ongoing investigation into customer closure separation (decapping) failures has made progress in the last few months.Bd performed a thorough investigation into this issue utilizing root cause analysis tools.Bd identified two potential root causes, and product was manufactured under different experimental conditions to evaluate the potential causes.The product samples were tested to verify key factors in production that may contribute to the separation of the cap from the stopper in automation lines delivering tubes to analyzers.During root cause analysis sessions and testing, bd identified our internal testing method for stopper function required improvement to better reflect the dynamics and forces seen at the decapping step in tube automation lines.This method has been released and continues to be 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.To date bd has not been able to identify a definitive root cause, but our r&d team will continue to investigate complaints for this defect.A complaint history review was conducted, and no trends were identified.Based on the severity and occurrence rate of this issue no corrective action will be taken at this time.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.H3 other text : see h10.

• 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: 16590436
• Report Number: 1917413-2023-00210
• Device Sequence Number: 14689394
• Product Code: JKA
• UDI-Device Identifier: 50382903678995
• UDI-Public: 50382903678995
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/18/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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