MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367842
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that while using bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes that there was discolored / abnormal additive form in the tube.The following information was provided by the initial reporter: customer states - "we have another qa issue and are working to determine how many we have of the affected lots." they appear as those moisture is inside the vacutainer and the order just arrived today (b)(6) 2023.".
Event or Problem Description
It was reported that while using bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes that there was discolored / abnormal additive form in the tube.The following information was provided by the initial reporter: customer states - "we have another qa issue and are working to determine how many we have of the affected lots." they appear as those moisture is inside the vacutainer and the order just arrived today (b)(6) 2023.".
Additional Manufacturer Narrative
The following fields have been updated with additional information: d.10 device available for eval? yes d.10 returned to manufacturer on: 15-sep-2023 h.6.Investigation summary: bd received ten (10) samples and two (2) photos for investigation.The photos were reviewed and the indicated failure mode for moisture with the incident lot was not observed.A mist spray pattern of the additive is observed inside the tube and meets the product specifications.Additionally, the customer samples along with one hundred (100) retention samples from bd inventory, were evaluated by visual examination and no issues were observed relating to moisture as all samples met specifications.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 is unable to be confirmed for the indicated failure mode of additive abnormality.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 3.6MG 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17508848
• Report Number: 1917413-2023-00774
• Device Sequence Number: 6101439
• Product Code: JKA
• UDI-Device Identifier: 50382903678421
• UDI-Public: 50382903678421
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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: 01/31/2024
• Device Catalogue Number: 367842
• Device Lot Number: 2292063
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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