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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PLUS PLASTIC SST TUBE; BLOOD COLLECTION TUBE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PLUS PLASTIC SST TUBE; BLOOD COLLECTION TUBE Back to Search Results
Catalog Number 367988
Device Problems False Negative Result (1225); False Positive Result (1227)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/15/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7282695, medical device expiration date: 2018-09-30, device manufacture date: 2017-10-09.Medical device lot #: 7321807, medical device expiration date: 2018-11-30, device manufacture date: 2017-11-17.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported during use of the bd vacutainer® plus plastic sst tube the customer is experiencing erroneous results with hiv tests, tests come back positive then come back negative.No samples are available.There was no report of injury or medical intervention.
 
Manufacturer Narrative
Investigation summary:bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for testing but no testing was conducted as the hiv complaints in question falls outside of the parameters set forth in our study protocols excluding the testing of any infectious disease.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.Investigation conclusion: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for testing but no testing was conducted as the hiv complaints in question falls outside of the parameters set forth in our study protocols excluding the testing of any infectious disease.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.Root cause description: based on the investigation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported during use of the bd vacutainer® plus plastic sst tube the customer is experiencing erroneous results with hiv tests, tests come back positive then come back negative.No samples are available.There was no report of injury or medical intervention.
 
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Brand Name
BD VACUTAINER® PLUS PLASTIC SST TUBE
Type of Device
BLOOD COLLECTION TUBE
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
MDR Report Key7322523
MDR Text Key101980878
Report Number1024879-2018-00069
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903679886
UDI-Public50382903679886
Combination Product (y/n)N
PMA/PMN Number
K050036
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 07/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number367988
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? No
Date Manufacturer Received02/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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