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

Model Number	367835
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	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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) 5.4mg blood collection tubes, the device experienced foreign matter in the tube (stopper).This event occurred one hundred times.The following information was provided by the initial reporter.The customer stated: fm on stopper.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-07-02.Investigation summary: bd received 1 samples and 3 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for foreign matter on the stopper was observed.Additionally, the customer samples were evaluated by visual examination and ftir analysis and the indicated failure mode for embedded foreign matter with the incident lot was observed.An ftir spectrum was collected on all points that contained the unidentified foreign matter.The spectra compared to a clean stopper control does show the unidentified foreign matter is rubber stopper material.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.This complaint has been confirmed for the indicated failure mode embedded foreign matter.Bd determined that the root cause of the indicated failure mode was attributed to manufacturing related.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes, the device experienced foreign matter in the tube (stopper).This event occurred one hundred times.The following information was provided by the initial reporter.The customer stated: fm on stopper.

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 5.4MG 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
• MDR Report Key: 12163345
• Report Number: 1917413-2021-00620
• Device Sequence Number: 14627754
• Product Code: JKA
• UDI-Device Identifier: 50382903678353
• UDI-Public: 50382903678353
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2021

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: 03/31/2022
• Device Model Number: 367835
• Device Catalogue Number: 367835
• Device Lot Number: 0316332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/08/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1