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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 367364
Device Problems Retraction Problem (1536); Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2022
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set there was a retraction issue and difficult to activate the safety feature.The following information was provided by the initial reporter.The customer stated: "this is a report about (1) difficulty to press the button and (2) needle retraction failure of utpbbcs.The customer reported as follows: hcps state that the push button is tight and it has become harder to press it than before.Another hcp has also experienced needle retraction failure.
 
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® ultratouch¿ push button blood collection set there was a retraction issue and difficult to activate the safety feature.The following information was provided by the initial reporter.The customer stated: "this is a report about (1) difficulty to press the button and (2) needle retraction failure of utpbbcs.The customer reported as follows: hcps state that the push button is tight and it has become harder to press it than before.Another hcp has also experienced needle retraction failure.
 
Manufacturer Narrative
Bd received 7 photos and 1 sample from the customer in support of this complaint.The photos and sample were evaluated and the issue of retraction failure was observed.Additionally, 10 retention samples from the bd inventory were functionally tested, and all retracted as expected, there were no difficulties pressing the retraction button.Bd was able to confirm the customer¿s indicated failure mode based on the photographs and sample provided.Bd was unable to determine a root cause for the reported issue.The device history records were reviewed with no issues being identified.There were no related quality notifications.All processes and final inspections comply with specification requirements.Complaints received for this device and reported conditions will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.H3 other text : see h.10.
 
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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 AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
UK 
Manufacturer (Section G)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
UK  
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15999615
MDR Text Key308154821
Report Number9617032-2022-01284
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 01/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2022
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 Number2230226
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2022
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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