MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	368589
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that tubes are having issues with hemolysis with a bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes.The following information was provided by the initial reporter: it was reported that tubes are having issues with hemolysis.Additional information provided by customer: it was drawn with no problems with a regular needle and sent through the tube system.We don¿t have any foam in the transport tubes but are going to try and get some to try out.Was it a difficult venipuncture? was there any ¿probing" at the venipuncture site? don¿t know.How long did it take to fill the tubes? don¿t know.Was the blood, if transferred from a syringe, forced into the tube? was not transferred.How long was the tourniquet left on the arm during venipuncture? she usually pops the tourniquet when blood starts coming, but not always.How are the tubes being mixed (gently or vigorously)? gentle inversion.Was the antiseptic used to cleanse the site allowed to dry before the venipuncture? yes.Was there any moisture present in the tube? did water, or other solutions, enter the tube? not that we noticed.Were all the tubes from this patient hemolyzed? was there a comparison of various samples from the same patient? some patients all tubes were hemolyzed, others one will the hemolyzed and the other not.Does the patient have a condition that may cause hemolysis? unknown.How long from collection to centrifugation? unknown.Were there any erroneous results due to the hemolysis? some did not cause an issue.Others we had to call the patient back.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode for hemolysis with the incident lot was observed in the photos.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Hemolysis can be caused by many sources, including certain patient pathological conditions, improper specimen collection, specimen processing, and specimen transport.Specimen collection factors that can contribute to hemolysis range from prolonged tourniquet time and improper venipuncture technique to transferring a sample from a syringe draw or iv catheter.Specimen processing factors include vigorous mixing or shaking of the specimen, not allowing the specimen to clot for the recommended amount of time, prolonged contact of serum or plasma with cells, and exposure to excessive heat or cold.Finally, mechanical trauma and other adverse conditions during transport of tubes can result in hemolysis.H3 other text : see section h.10.
Event or Problem Description
It was reported that tubes are having issues with hemolysis with a bd vacutainer® k2 edta (k2e) 18 mg blood collection tubes.The following information was provided by the initial reporter: it was reported that tubes are having issues with hemolysis.Additional information provided by customer: it was drawn with no problems with a regular needle and sent through the tube system.We don¿t have any foam in the transport tubes but are going to try and get some to try out.Was it a difficult venipuncture? was there any ¿probing"" at the venipuncture site? don¿t know.How long did it take to fill the tubes? don¿t know.Was the blood, if transferred from a syringe, forced into the tube? was not transferred.How long was the tourniquet left on the arm during venipuncture? she usually pops the tourniquet when blood starts coming, but not always.How are the tubes being mixed (gently or vigorously)? gentle inversion.Was the antiseptic used to cleanse the site allowed to dry before the venipuncture? yes.Was there any moisture present in the tube? did water, or other solutions, enter the tube? not that we noticed.Were all the tubes from this patient hemolyzed? was there a comparison of various samples from the same patient? some patients all tubes were hemolyzed, others one will the hemolyzed and the other not.Does the patient have a condition that may cause hemolysis? unknown.How long from collection to centrifugation? unknown.Were there any erroneous results due to the hemolysis? some did not cause an issue.Others we had to call the patient back.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 18 MG 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: 9234420
• Report Number: 1917413-2019-02250
• Device Sequence Number: 3103340
• Product Code: JKA
• UDI-Device Identifier: 50382903685894
• UDI-Public: 50382903685894
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: BK980011
• Number of Events Summarized: 1
• Summary Report (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): 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 368589
• Device Lot Number: 8345629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other