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

Model Number	367859
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 5.4 mg blood collection tube there was a broken lid/cap/hemogard shield.The following information was provided by the initial reporter.The customer stated: the device had a "damaged cap.".
Additional Manufacturer Narrative
H6: investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for cocked stopper with the incident lot was observed.Additionally, 90 retention samples from bd inventory were evaluated by visual examination and the issue of cocked stopper was not observed.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.H3 other text : see h10.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 5.4 mg blood collection tube there was a broken lid/cap/hemogard shield.The following information was provided by the initial reporter.The customer stated: the device had a "damaged cap.".

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 5.4 MG 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
• MDR Report Key: 11741835
• Report Number: 1917413-2021-00349
• Device Sequence Number: 3157804
• Product Code: JKA
• UDI-Device Identifier: 50382903678599
• UDI-Public: 50382903678599
• 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): 05/18/2021

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 Model Number: 367859
• Device Catalogue Number: 367859
• Device Lot Number: 0227188
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1