MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367844
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tube the tube was used after the expiration date.The following information was provided by the initial reporter.The customer stated: "the tubes were used past their expiration date.For our study in children, we draw blood in k2 edta 7.2mg 4.0 ml tubes (ref 367844), and recently realized that some of our tubes had expired a few months ago.In order to account for any derivation in our data and results.I wanted to inquire as to whether the expiration date for the tubes pertains to the vacuum, the reagent, or both.".
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.As noted in bds instructions for use (ifu), do not use tubes after their expiration date.Tubes expire on the last day of the month and year indicated.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.H3 other text : see h10.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tube the tube was used after the expiration date.The following information was provided by the initial reporter.The customer stated: "the tubes were used past their expiration date.For our study in children, we draw blood in k2 edta 7.2mg 4.0 ml tubes (ref (b)(6)), and recently realized that some of our tubes had expired a few months ago.In order to account for any derivation in our data and results.I wanted to inquire as to whether the expiration date for the tubes pertains to the vacuum, the reagent, or both.".

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBE
• 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: 13119266
• Report Number: 1917413-2021-01093
• Device Sequence Number: 4518136
• Product Code: JKA
• UDI-Device Identifier: 50382903678445
• UDI-Public: 50382903678445
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/19/2022

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 Model Number: 367844
• Device Catalogue Number: 367844
• Device Lot Number: UNKNOWN
• 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: 12/03/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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