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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 Product Quality Problem (1506); Difficult or Delayed Activation (2577)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/16/2021
Event Type  Injury  
Manufacturer Narrative
There were multiple medical device types reported to be involved. The information for each 510(k) number is as follows: medical device type: fpa. Investigation summary: bd had not received samples or photos for investigation. Therefore, 30 retention samples from bd inventory were evaluated by visual inspection and no issues were observed relating to damaged components (retraction failure) as all samples met specifications. 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 is unable to be confirmed for the indicated failure mode damaged components (retraction failure). Bd was not able to identify a root cause for the indicated failure mode.
 
Event Description
It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set there was a needle stick injury - post use and retraction issue- delay or no retraction. The following information was provided by the initial reporter. The customer stated: "sustained a needle stick injury while getting butter fly retracted post attempting blood collection of a patient. Was unable to retract butterfly sharp by using mechanism, sustained injury to left thumb. Attempted first aid at the scene. ".
 
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Brand NameBD VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET
Type of DeviceBLOOD 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12497519
MDR Text Key272214867
Report Number1024879-2021-00641
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K153309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number367364
Device Catalogue Number367364
Device Lot Number1096954
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/20/2021 Patient Sequence Number: 1
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