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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 Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Information (3190)
Date of Event 11/28/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode for (b)(6) with the incident lot was observed.Additionally, 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 contained foreign matter.
 
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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 Key7443307
Report Number1024879-2018-00508
Device Sequence Number16542037
Product Code JKA
UDI-Device Identifier50382903679817
UDI-Public50382903679817
Combination Product (Y/N)N
Initial Reporter StatePA
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) 04/17/2018
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 Catalogue Number367981
Device Lot Number6084725
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/28/2016
Initial Report FDA Received Date04/19/2018
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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