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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 Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 failure of product to contain blood/medication.The cut tubing event occurred 2 times.The leakage event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "there was a cut in the tubing, resulting in blood leakage.".
 
Manufacturer Narrative
H6.Investigation summary: bd received 7 photos and 7 customer samples from the customer for review and analysis.The samples and photos were visually evaluated, and the customer¿s indicated failure mode of damaged tubing was observed.Additionally, the customer samples were subjected to functional testing and the customer¿s indicated failure mode of leakage was observed as 1 of the 27 customer samples failed testing.Therefore, the failure mode of leakage can be confirmed based on the customer sample testing results.Additionally, 100 retention samples from the bd inventory were subjected to a visual examination and 30 samples were subjected to functional testing for cut tubing and leakage and, both issues of cut tubing and leakage were observed.Therefore, the reported failure mode of leakages and damaged tubing can be confirmed based on the retain sample testing results.The device history record was reviewed with no issues being identified, and there were no related quality notifications.All process and final inspections comply with specification requirements.Bd is able to confirm the customer¿s reported failures with the retain sample and customer sample testing results.Bd has initiated further root cause investigation relating to the issue of damaged tubing and leakage through corrective and preventive actions.Capa pr #4688284 has been created in relation to this issue to document the investigation path, root cause analysis and remediation plan to include corrective and preventive actions.
 
Event Description
It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set there was failure of product to contain blood/medication.The cut tubing event occurred 2 times.The leakage event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "there was a cut in the tubing, resulting in blood leakage.".
 
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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 Key13738607
MDR Text Key287267838
Report Number1024879-2022-00130
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903673648
UDI-Public50382903673648
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153309
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 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2023
Device Model Number367364
Device Catalogue Number367364
Device Lot Number1228667
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2021
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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