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

Model Number 367988

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

Patient Problems Hemolysis (1886); Test Result (2695)

Event Date 03/03/2020

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 erroneous results and hemolysis occurred with a bd vacutainer® sst¿ blood collection tubes.The following information was provided by the initial reporter: spoke with the customer and she states that the patient was initially drawn in the clinic and the phlebotomist assured her that she drew an sst tube and then the edta tube, and did not transfer any blood from the edta tube to the sst tube.The sample was slightly hemolyzed, and all the values were low.The patient was redrawn in the er and the sst results were all normal, and they also ran a na on the edta tube, which was also normal.Additionally, on 2020-03-09 the customer provided the following additional information: the specimen was drawn in an sst on (b)(6) 2020 at 1115, left to clot for 30 minutes, then spun at 3305 rpm for 10 minutes.Sample showed slight hemolysis and spun again for another 10 minutes.Sample was refrigerated before and during transportation.Sample was run and reported out at 1809 on (b)(6) 2020.The sample shows slight hemolysis.), what instrument was used? (ortho vitros 5600), initial result drawn at 1115 (b)(6) 2020, repeated result from er drawn at 1930 (b)(6) 2020, reference range.Sodium: 114 critical, 138, 137-145 mmol/l.Potassium: 3.7, 3.8, 3.5-5.1 mmol/l.Chloride: 85, 100, 98-107 mmol/l.Co2: 16.5, 25.3 22.0-30.0 mmol/l.Glucose : 71, 94, 70-110 mg/dl.Bun: 14.6, 21.2, 7.0-20.0 mg/dl.Creatinine: 0.5, 0.7, 0.7-1.5 mg/dl.Calcium: 8.3, 10.2, 8.4-10.6 mg/dl.Bili total: 0.5, 0.5, 0.2-1.3 mg/dl.Alk phos: 46, 65, 36-126 unit/l.Ast: 31, 25, 15-46 unit/l.Alt: 15, 29, 13-69 unit/l.Total prot: 6.4, 8.4, 6.3-8.2 g/dl.Albumin: 3.6, 4.8, 3.5-5.0 g/dl.Globulin: 2.8, 3.6, 2.5-3.6 g/dl.Pt drawn and results came back as critically low for sodium and low for chloride and calcium.When the pt was redrawn and sample run in er, results came back positive.Initial draw done at clinic and second draw was done at the facility.All testing was performed at the same site at the mc.Pt was a difficult draw.Customer could not provide the lot as it was covered with a facility label.

Manufacturer Narrative

Investigation: bd had not received samples or photos from the customer facility for evaluation.Retention samples of the incident lot were selected from bd inventory for testing and upon completion, no issues relating to erroneous results and hemolysis 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.

Event Description

It was reported that erroneous results and hemolysis occurred with a bd vacutainer® sst¿ blood collection tubes.The following information was provided by the initial reporter: spoke with the customer and she states that the patient was initially drawn in the clinic and the phlebotomist assured her that she drew an sst tube and then the edta tube, and did not transfer any blood from the edta tube to the sst tube.The sample was slightly hemolyzed, and all the values were low.The patient was redrawn in the er and the sst results were all normal, and they also ran a na on the edta tube, which was also normal.Additionally, on 2020 (b)(6) the customer provided the following additional information: the specimen was drawn in an sst on 3-3-20 at 1115, left to clot for 30 minutes, then spun at 3305 rpm for 10 minutes.Sample showed slight hemolysis and spun again for another 10 minutes.Sample was refrigerated before and during transportation.Sample was run and reported out at 1809 on (b)(6) 2020.The sample shows slight hemolysis.), what instrument was used? (ortho vitros 5600).Initial result drawn at 1115 (b)(6) 2020.Repeated result from er drawn at 1930 (b)(6) 2020 reference range sodium 114 critical 138 137-145 mmol/l potassium 3.7 3.8 3.5-5.1 mmol/l chloride 85 100 98-107 mmol/l co2 16.5 25.3 22.0-30.0 mmol/l glucose 71 94 70-110 mg/dl bun 14.6 21.2 7.0-20.0 mg/dl creatinine 0.5 0.7 0.7-1.5 mg/dl calcium 8.3 10.2 8.4-10.6 mg/dl bili total 0.5 0.5 0.2-1.3 mg/dl alk phos 46 65 36-126 unit/l ast 31 25 15-46 unit/l alt 15 29 13-69 unit/l total prot 6.4 8.4 6.3-8.2 g/dl albumin 3.6 4.8 3.5-5.0 g/dl globulin 2.8 3.6 2.5-3.6 g/dl pt drawn and results came back as critically low for sodium and low for chloride and calcium.When the pt was redrawn and sample run in er, results came back positive.Initial draw done at clinic and second draw was done at the facility.All testing was performed at the same site at the mc.Pt was a difficult draw.Customer could not provide the lot as it was covered with a facility label.

• 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: 9884503
• MDR Text Key: 188658247
• Report Number: 1024879-2020-00225
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679886
• UDI-Public: 50382903679886
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Model Number: 367988
• Device Catalogue Number: 367988
• Device Lot Number: 9254091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR