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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® C&S PRESERVATIVE URINE TUBE; TRANSPORT CULTURE MEDIUM
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BECTON, DICKINSON & CO. BD VACUTAINER® C&S PRESERVATIVE URINE TUBE; TRANSPORT CULTURE MEDIUM Back to Search Results
Catalog Number 364951
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 05/09/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.
 
Event or Problem Description
It was reported that the bd vacutainer® c&s preservative urine tube gave erroneous results.No report of injury or medical intervention.No report of blood exposure to mucous membrane.
 
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Brand Name
BD VACUTAINER® C&S PRESERVATIVE URINE TUBE
Common Device Name
TRANSPORT CULTURE MEDIUM
Manufacturer (Section D)
BECTON, DICKINSON & CO.
150 south 1st avenue
broken bow NE 68822
MDR Report Key7602999
Report Number1917413-2018-02661
Device Sequence Number2221472
Product Code JSM
UDI-Device Identifier50382903649513
UDI-Public50382903649513
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K024240
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other,user facility
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/29/2018
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 Number364951
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/09/2016
Initial Report FDA Received Date06/14/2018
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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