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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD HEPARIN TUBE; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON DICKINSON UNSPECIFIED BD HEPARIN TUBE; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number UNKNOWN
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems Test Result (2695); No Code Available (3191)
Event Date 08/19/2019
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.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 corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
 
Event Description
It was reported that an unspecified bd heparin tube gave erroneous results.The following information was provided by the initial reporter: "heparin green top vacutainer tube showed positive/elevated troponin levels that resulted in an in-patient hospitalization which lasted three days beginning on (b)(6) 2019.After three days and more testing the troponin levels were found to be wnl and not elevated.Event was reported by the lab manager to siemens as it was originally thought to be caused by their dimension chemistry analyzer.Upon further investigation by the lab manager, she now believes the event was related to the vacutainer and not the siemens analyzer.The lab manager did not report this incident to bd.It is unknown if siemens reported incident to bd.The event of high troponin levels occurred ¿about 3 times¿ and was resolved by using a ¿sample insert.¿ they use a sample cup.At the time of this report no further information was available."".
 
Manufacturer Narrative
H.6.Investigation: the lot number for this issue could not be provided by the customer.Sample was not returned.To assure high quality specimens, several factors are key.Included, but not limited to this are: proper phlebotomy technique to minimize hemolysis and platelet activation, proper tube fill volume to assure the proper blood-to-additive ration, gentle and thorough mixing, proper centrifugation conditions-g force and time, and storage conditions.A discard tube must be used when using a winged blood collection set for venipuncture in order to fill the blood collection set tubing¿s ¿dead space¿ with blood.It is not necessary to fill the discard tube completely.This step will ensure maintenance of the proper blood-additive-ratio of the specimen.The discard tube should be a non-additive or coagulation tube.Adherence to the recommended specimen handling and processing steps will facilitate acceptable specimen quality and overall performance for reliable analytical outcomes.Evaluation of laboratory instrumentation regarding reproducibility/repeatability may be of value.A review of specimen handling parameters would be of value for this tube type.Attached are our pst¿ techtalk and a publication addressing heparin plasma testing in clinical chemistry.We will continue to monitor for additional complaints and emerging trends.
 
Event Description
It was reported that an unspecified bd heparin tube gave erroneous results.The following information was provided by the initial reporter: "heparin green top vacutainer tube showed positive/elevated troponin levels that resulted in an in-patient hospitalization which lasted three days beginning on (b)(6) 2019.After three days and more testing the troponin levels were found to be wnl and not elevated.Event was reported by the lab manager to siemens as it was originally thought to be caused by their dimension chemistry analyzer.Upon further investigation by the lab manager, she now believes the event was related to the vacutainer and not the siemens analyzer.The lab manager did not report this incident to bd.It is unknown if siemens reported incident to bd.The event of high troponin levels occurred ¿about 3 times¿ and was resolved by using a ¿sample insert.¿ they use a sample cup.At the time of this report no further information was available."".
 
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Brand Name
UNSPECIFIED BD HEPARIN TUBE
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key9979166
MDR Text Key188327025
Report Number2243072-2020-00628
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 05/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
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
Date Manufacturer Received03/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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