MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367986

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Test Result (2695)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that there are erroneous potassium and calcium results with a bd vacutainer® sst¿ blood collection tubes.The following information was provided by the initial reporter: (1 of 4 complaints) it was reported that there are erroneous potassium and calcium results.(b)(6): 0.8 calcium, 27.62 potassium.Additionally, on 2020-01-22 the bd sales consultant provided the following additional information: spoke with the customer.She states that the samples were drawn by the phlebotomy supervisor and a phlebotomist using a straight needle or butterfly.The phlebotomy supervisor insists that she did not pour the contents of the edta tube into the sst tube.The phlebotomist did not deny or confirm what she did.The customer is not aware if the samples clotted, as the tubes were processed in the lab.She will send samples of unused tubes.She will get back to me with the results of re-draws.Results: the customer called back today with repeat results: 8.4 ca, and 3.59 k+; 8.7 ca, and 4.7 k+.Previous results for one of the patients were: 8.5 ca, and 4.3 k+.She will call if the other patient returns for repeat blood work.

Event Description

It was reported that there are erroneous potassium and calcium results with a bd vacutainer® sst¿ blood collection tubes.The following information was provided by the initial reporter: (1 of 4 complaints).It was reported that there are erroneous potassium and calcium results.(b)(6) : 0.8 calcium,27.62 potassium additionally, on 2020 (b)(6) the bd sales consultant provided the following additional information: spoke with the customer.She states that the samples were drawn by the phlebotomy supervisor and a phlebotomist using a straight needle or butterfly.The phlebotomy supervisor insists that she did not pour the contents of the edta tube into the sst tube.The phlebotomist did not deny or confirm what she did.The customer is not aware if the samples clotted, as the tubes were processed in the lab.She will send samples of unused tubes.She will get back to me with the results of re-draws.Results: the customer called back today with repeat results: 8.4 ca, and 3.59 k+; 8.7 ca, and 4.7 k+.Previous results for one of the patients were: 8.5 ca, and 4.3 k+.She will call if the other patient returns for repeat blood work.

Manufacturer Narrative

Investigation: bd received samples from the customer facility for investigation.The customer samples were tested and no issues relating to erroneous result were observed as all results demonstrated satisfactory performance.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.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 9687255
• MDR Text Key: 179116254
• Report Number: 1024879-2020-00068
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679862
• UDI-Public: 50382903679862
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 367986
• Device Catalogue Number: 367986
• Device Lot Number: 9151849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other