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

Model Number 367862

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

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 Description

It was reported the bd vacutainer® k2 edta (k2e) plus blood collection tubes experienced hemolysis.The following information was provided by the initial reporter.The customer stated: "customer would like a call back in regards to processing specimens with product 367862." (b)(6) 2021 :the client called and wanted to know why he was having trouble getting the plasma to separate from the cells in the edta tubes.He indicate that the tubes were completely red after centrifugation.He indicated that they were on ice.The tubes sound like they are hemolyzed.

Manufacturer Narrative

H6: 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.

Event Description

It was reported the bd vacutainer® k2 edta (k2e) plus blood collection tubes experienced hemolysis.The following information was provided by the initial reporter.The customer stated: "customer would like a call back in regards to processing specimens with product 367862." (b)(6) 2021:the client called and wanted to know why he was having trouble getting the plasma to separate from the cells in the edta tubes.He indicate that the tubes were completely red after centrifugation.He indicated that they were on ice.The tubes sound like they are hemolyzed.

• Brand Name: BD VACUTAINER K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11543980
• MDR Text Key: 254843531
• Report Number: 1917413-2021-00208
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678629
• UDI-Public: 50382903678629
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

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
• Device Operator: Other
• Device Model Number: 367862
• Device Catalogue Number: 367862
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/22/2021
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1