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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO. BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 366667
Medical Device Problem Code Short Fill (1575)
Health Effect - Clinical Code No Information (3190)
Date of Event 09/15/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7016654, expiration date: 05/31/2018, manufacture date: 01/16/2017.Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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® lithium heparinn (lh) 56 usp units blood collection tubes were under filling.
 
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Brand Name
BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES
Common Device Name
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO.
150 south 1st avenue
broken bow NE 68822
MDR Report Key7515007
Report Number1917413-2018-01411
Device Sequence Number13812576
Product Code JKA
UDI-Device Identifier50382903666671
UDI-Public50382903666671
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K901449
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/01/2018
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 Date09/30/2017
Device Catalogue Number366667
Device Lot Number6124740
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/15/2017
Initial Report FDA Received Date05/15/2018
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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