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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
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) 10.8mg blood collection tube there was rubber stopper remained in tube.The following information was provided by the initial reporter.The customer stated: "the rubber stopper remains in the tube.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 2 photos form the customer in support of this complaint.The photos were evaluated and the issue of closure assembly was observed.Additionally, 10 retention samples were visually inspected and functionally tested with no issues being identified as all tubes were within specification limits and no issues were identified with the hemogard closure assembly.Bd was able to confirm the customer¿s indicated failure with the photos provided; however, was not able to be duplicated in the retention testing.The exact cause for the customer's failure mode could not be determined.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.H3 other text : see h.10.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 10.8mg blood collection tube there was rubber stopper remained in tube.The following information was provided by the initial reporter.The customer stated: "the rubber stopper remains in the tube.".
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 10.8mg blood collection tube there was rubber stopper remained in tube.The following information was provided by the initial reporter.The customer stated: "the rubber stopper remains in the tube.".
Additional Manufacturer Narrative
The following fields have been updated with additional/corrected information: h.6.Investigation summary: bd had not received samples, but 2 photos were returned by the customer in support of this complaint catalog 367899, lot number 2166071.The photos do show the customer¿s failure mode as the hemogard closure is separated from the stopper and the lot shown on the tube label is 2166071.100 retentions were visually inspected with no issues being identified.10 production lot in-house retention tubes were inspected with 0 visible defects.A draw test was performed at the manufacturing site on the 10-production lot in-house retention tubes.All tubes were within specification limits.No issues were identified with the hemogard closure assembly.The 100 retentions 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.20 retain samples were evaluated by functional testing and the issue of closure separation 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.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 condition 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 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 ; 8015296192
• MDR Report Key: 15760243
• Report Number: 1917413-2022-00702
• Device Sequence Number: 20377161
• Product Code: JKA
• UDI-Device Identifier: 50382903678995
• UDI-Public: 50382903678995
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 12/22/2023

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: 10/26/2022
• Supplement Date Received by Manufacturer: 11/28/2022; 12/22/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/16/2022; 01/05/2024
• 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