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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO. BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 364816
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/06/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Investigation: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for molding defects with the incident lot was 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 a bd vacutainer® acd solution b blood collection tubes has molding defects before use.No injury or medical intervention.
 
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Brand Name
BD VACUTAINER® ACD SOLUTION B 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 Key7424154
Report Number1917413-2018-00728
Device Sequence Number13716143
Product Code JKA
UDI-Device Identifier50382903648165
UDI-Public50382903648165
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
PREAMENDMENT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/10/2018
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 Date08/31/2017
Device Catalogue Number364816
Device Lot Number5210970
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/06/2016
Initial Report FDA Received Date04/11/2018
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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