MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-26 for BD VACUTAINER? SST? BLOOD COLLECTION TUBES 367988 manufactured by Becton, Dickinson & Co., (bd).
[188658247]
A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188658248]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1024879-2020-00225 |
| MDR Report Key | 9884503 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-09-11 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON, DICKINSON & CO., (BD) |
| Manufacturer Street | 1575 AIRPORT ROAD |
| Manufacturer City | SUMTER SC 29153 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29153 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VACUTAINER? SST? BLOOD COLLECTION TUBES |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | JKA |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 367988 |
| Catalog Number | 367988 |
| Lot Number | 9254091 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO., (BD) |
| Manufacturer Address | 1575 AIRPORT ROAD SUMTER SC 29153 US 29153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-26 |