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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367981
Medical Device Problem Code Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/10/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode with the incident lot was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.
 
Event or Problem Description
It was reported that bd vacutainer® sst¿ blood collection tubes hemolysed.No report of injury or medical intervention.No report of blood exposure to mucous membrane.
 
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Brand Name
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
Common Device Name
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
MDR Report Key7587063
Report Number1024879-2018-02081
Device Sequence Number1799642
Product Code JKA
UDI-Device Identifier50382903679817
UDI-Public50382903679817
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
BK050036
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/17/2018
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
Operator of Device Other
Device Expiration Date09/30/2016
Device Catalogue Number367981
Device Lot Number5282890
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/10/2016
Initial Report FDA Received Date06/11/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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