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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 INTRAVASCULAR ADMINISTRATION SET

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BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 367364
Device Problems Product Quality Problem (1506); Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address: (b)(6). Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: bd had not received samples or photos for evaluation. Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted. 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.
 
Event Description
It was reported that bd vacutainer® ultratouch¿ push button blood collection set had the hub separate from the device and had a retraction issue. The following information was provided by the initial reporter: " upon opening he packaging of the ultratouch push button wingset, it was noticed that the winged component of the ultratouch was found to be separated from the main translucent body. Needle remained intact and not retracted. ".
 
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Brand NameBD VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12193131
MDR Text Key262499111
Report Number9617032-2021-00790
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 06/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2021
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 NumberUNKNOWN
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 Received06/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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