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 AND COMPANY (BD) BD VACUTAINER® Z (NO ADDITIVE) URINE TUBE - CONICAL; SPECIMEN TRANSPORT AND STORAGE CONTAINER
  • 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 AND COMPANY (BD) BD VACUTAINER® Z (NO ADDITIVE) URINE TUBE - CONICAL; SPECIMEN TRANSPORT AND STORAGE CONTAINER Back to Search Results
Catalog Number 365000
Device Problems Short Fill (1575); Volume Accuracy Problem (1675)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported during use the bd vacutainer® z (no additive) urine tube - conical experienced underfill or low draw of a tube.This event occurred 50 times.The following information was provided by the initial reporter: "urine tubes does not fill up when using urine cup.The customer had filled 10 urine tubes and was expecting all 10 tubes to be filled up with 9.5 ml urine".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-04-14 h.6.Investigation summary bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for draw volume with the incident lot was not observed.Testing of the customer samples was performed and draw volume was not observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd has initiated further investigation relating to this issue through capa 260774.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.
 
Event Description
It was reported during use the bd vacutainer® z (no additive) urine tube - conical experienced underfill or low draw of a tube.This event occurred 50 times.The following information was provided by the initial reporter: "urine tubes does not fill up when using urine cup.The customer had filled 10 urine tubes and was expecting all 10 tubes to be filled up with 9.5 ml urine".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD VACUTAINER® Z (NO ADDITIVE) URINE TUBE - CONICAL
Type of Device
SPECIMEN TRANSPORT AND STORAGE CONTAINER
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
UK 
MDR Report Key9905427
MDR Text Key187028898
Report Number1917413-2020-00350
Device Sequence Number1
Product Code KDT
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 05/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2020
Device Catalogue Number365000
Device Lot Number8303621
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2020
Date Manufacturer Received03/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-