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

Model Number	367844
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
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) 7.2mg blood collection tubes, the device experienced broken lid/cap/hemogard shield.The following information was provided by the initial reporter.The customer stated: "internal plug cracking.".
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for defective stopped molding with the incident lot was observed.Bd determined that the root cause of the indicated failure mode was attributed to manufacturing related.The cause of the slit in the stopper occurred at the molding press, where the stopper did not cure properly thereby leading to the molding defect seen based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes, the device experienced broken lid/cap/hemogard shield.The following information was provided by the initial reporter.The customer stated: "internal plug cracking.".

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 7.2MG 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: 11898333
• Report Number: 1917413-2021-00453
• Device Sequence Number: 11079207
• Product Code: JKA
• UDI-Device Identifier: 50382903678445
• UDI-Public: 50382903678445
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 07/07/2021

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: 09/30/2021
• Device Model Number: 367844
• Device Catalogue Number: 367844
• Device Lot Number: 0133329
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1