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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED VACUTAINER BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON DICKINSON UNSPECIFIED VACUTAINER BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number UNKNOWN
Device Problems Coagulation in Device or Device Ingredient (1096); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2020
Event Type  Injury  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd (b)(4) has been listed in sections manufacturer name, city and state and manufacturer site.And (b)(4) registration number has been used for the manufacture report number.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.(b)(4).
 
Event Description
It was reported the unspecified vacutainer blood collection tubes experienced clotting/micro clots/fibrin clots, poor barrier separation of sample, erroneous results (2 of 3).This event occurred 2 times.The following information was provided by the initial reporter.It is reported customer experienced clotting, erroneous results and poor barrier separation."plasma is clotting in the pst tubes.The specimen is fine in edta and na citrate.Patient originally presented to emergency on (b)(6) in the afternoon.The day shift tech ran the sample with an indices because it looked lipemic.The lipemia index was 9.They then put the sample up for ultra centrifugation and passed on information to evening shift.The evening shift tech relayed information to the original day shift tech the next day (sunday evening at shift change) that the sample was strange when being removed from ultra centrifuge and that the small amount of main sample that was left over was completely clotted.The evening shift tech ran the ultra centrifuged sample and results did not change significantly but lipemia index went to 1" cbc and coag specimens plasma show no lipemia.On sunday, patient was readmitted to emergency, and sample was collected on patient and tech noticed plasma looked like it had not separated properly upon spinning.The tech who noted this was also the same tech who noticed the appearance of lipemia in the sample from the day before.However, they were not aware of what happened on the evening shift the previous nite because evening tech did not make them aware until they arrived for their evening shift that nite.Because of the poor separation with flocculant matter seen as well the tech aliquoted and respun plasma in regular centrifuge.Plasma separated and was clear.This caused the tech to do some detective work.Plasma from saturday¿s specimen: completely clotted in pst tube but normal and unclotted in airfuged specimen.Plus the edta and citrate tubes from previous day were fine.Inquired with biochemist on call for any advice and was given no guidance.Tech decided to collect sst and pst with patients next blood work.No clotting problems or lipemic, flocculant serum noted in sst.Pst collected at same time, rapidly clouding after centrifugation and not completely separated.Ran both samples for ordered test and results compared but pst showed lipemia index of 3.Left note for accession to collect this patient¿s chemistry in sst.
 
Event Description
It was reported the unspecified vacutainer blood collection tubes experienced clotting/micro clots/fibrin clots, poor barrier separation of sample, erroneous results (2 of 3).This event occurred 2 times.The following information was provided by the initial reporter.It is reported customer experienced clotting, erroneous results and poor barrier separation."plasma is clotting in the pst tubes.The specimen is fine in edta and na citrate.Patient originally presented to emergency on (b)(6) in the afternoon.The day shift tech ran the sample with an indices because it looked lipemic.The lipemia index was 9.They then put the sample up for ultra centrifugation and passed on information to evening shift.The evening shift tech relayed information to the original day shift tech the next day (sunday evening at shift change) that the sample was strange when being removed from ultra centrifuge and that the small amount of main sample that was left over was completely clotted.The evening shift tech ran the ultra centrifuged sample and results did not change significantly but lipemia index went to 1" cbc and coag specimens plasma show no lipemia.On sunday, patient was readmitted to emergency, and sample was collected on patient and tech noticed plasma looked like it had not separated properly upon spinning.The tech who noted this was also the same tech who noticed the appearance of lipemia in the sample from the day before.However, they were not aware of what happened on the evening shift the previous nite because evening tech did not make them aware until they arrived for their evening shift that nite.Because of the poor separation with flocculant matter seen as well the tech aliquoted and respun plasma in regular centrifuge.Plasma separated and was clear.This caused the tech to do some detective work.Plasma from saturday¿s specimen: completely clotted in pst tube but normal and unclotted in airfuged specimen.Plus the edta and citrate tubes from previous day were fine.Inquired with biochemist on call for any advice and was given no guidance.Tech decided to collect sst and pst with patients next blood work.No clotting problems or lipemic, flocculant serum noted in sst.Pst collected at same time, rapidly clouding after centrifugation and not completely separated.Ran both samples for ordered test and results compared but pst showed lipemia index of 3.Left note for accession to collect this patient¿s chemistry in sst.
 
Manufacturer Narrative
H6: investigation summary bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific material and lot number associated with this complaint.A device history review could not be completed as no batch number was provided.See h.10.
 
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Brand Name
UNSPECIFIED VACUTAINER BLOOD COLLECTION TUBE
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11015257
MDR Text Key226296338
Report Number2243072-2020-02073
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 12/29/2020
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 Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/27/2020
Initial Date FDA Received12/15/2020
Supplement Dates Manufacturer Received12/29/2020
Supplement Dates FDA Received12/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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