Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON, DICKINSON & CO. BD VACUTAINER® C&S PRESERVATIVE URINE TUBE; TRANSPORT CULTURE MEDIUM Back to Search Results
Catalog Number 364951
Medical Device Problem Code Short Fill (1575)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/05/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).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.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode was not observed as all samples met specifications.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® c&s preservative urine tube had low vacuum.No report of injury or medical intervention.No report of blood exposure to mucous membrane.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7591918
Report Number1917413-2018-01656
Device Sequence Number209944
Product Code JSM
UDI-Device Identifier50382903649513
UDI-Public50382903649513
Combination Product (Y/N)N
Initial Reporter CountryMX
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 Other
Type of Report Initial
Report Date (Section B) 05/18/2018
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 Number364951
Device Lot Number6029856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/05/2017
Initial Report FDA Received Date06/12/2018
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;
-
-