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 INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE
  • 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 INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 367324
Device Problems Fluid/Blood Leak (1250); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2023
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 when using the bd vacutainer® push button blood collection set there was blood leakage or other sample leakage from the device other than the insertion site or needle tip.The following information was provided by the initial reporter.The customer stated: blood leakage from damage on the tubing.
 
Manufacturer Narrative
The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 30-mar-2023.Bd received 1 physical sample and 4 photos for investigation.The photos were reviewed and the customer¿s indicated failure modes for a hole and leakage were observed.The sample was tested and the indicated failure modes for a hole and leakage were observed.A hole was observed in the tubing, which would allow fluid to leak from the device.As the unit is opened, it cannot be determined with certainty whether the damage occurred in the user environment or during manufacturing.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure modes "hole in product" and "leakage".Bd was not able to identify a root cause for the indicated failure mode.No other similar complaints were reported for the implicated lot.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
 
Event Description
It was reported when using the bd vacutainer® push button blood collection set there was blood leakage or other sample leakage from the device other than the insertion site or needle tip.The following information was provided by the initial reporter.The customer stated: "blood leakage from damage on the tubing.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16638015
MDR Text Key312491243
Report Number1710034-2023-00331
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903673242
UDI-Public50382903673242
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K030573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2024
Device Model Number367324
Device Catalogue Number367324
Device Lot Number2131350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/07/2023
Initial Date FDA Received03/29/2023
Supplement Dates Manufacturer Received04/13/2023
Supplement Dates FDA Received04/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-