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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 367364
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2022
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set there was blood leakage or other sample leakage from the device other than the insertion site or needle tip and failure of product to contain blood/medication.The following information was provided by the initial reporter.The customer stated: "leakage occurred when syringe is attached to wing set resulting in blood spillage.Leakage occurred when the syringe was attached to the wing set resulting in blood spillage." correct ppe was being worn, but there was blood that was not contained leaking out of the device.
 
Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for each 510(k) number is as follows:.Common device name: intravascular administration set.Medical device type: fpa.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® ultratouch¿ push button blood collection set there was blood leakage or other sample leakage from the device other than the insertion site or needle tip and failure of product to contain blood/medication.The following information was provided by the initial reporter.The customer stated: "leakage occurred when syringe is attached to wing set resulting in blood spillage.Leakage occurred when the syringe was attached to the wing set resulting in blood spillage." correct ppe was being worn, but there was blood that was not contained leaking out of the device.
 
Manufacturer Narrative
H.6.Investigation summary: bd did not receive photos or samples from the customer in support of this complaint.Therefore, 30 retain samples from the bd inventory were subjected to functional testing and the issue of leakage was not observed.Bd is unable to confirm the customer¿s reported failure modes of leakage ¿ other and splatter based on retain sample testing analysis.Bd was unable to determine a root cause for the reported issue.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.
 
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Brand Name
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
Manufacturer (Section G)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15757221
MDR Text Key305244047
Report Number1024879-2022-00657
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903673648
UDI-Public50382903673648
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number367364
Device Catalogue Number367364
Device Lot Number2146548
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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