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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IV SET VENTED ARD AP INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON IV SET VENTED ARD AP INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 388000
Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964)
Patient Problems Underdose (2542); Insufficient Information (4580)
Event Date 01/18/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number. The reported lot # [1018034] was not found for the reported catalog # [388000]. Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that infusion fluid/medicine leaked from the iv set vented ard ap and onto the patient. As a result, the patient did not receive the prescribed dose. The following information was provided by the initial reporter: "the infusion tube leaks from the point where you connect it to the iv cannula. Infusion fluid or medicine leaks on patients skin and clothes. Patient did not receive the prescribed dose of medication intended as end result. This product is a new iv set in this department. There has been several leakage incidents since starting to use this product. Most of the problems occur when bcv is attached to the iv-cannula and iv set is connected to bcv. ".
 
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Brand NameIV SET VENTED ARD AP
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11341445
MDR Text Key232350829
Report Number2243072-2021-00350
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
NA
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,Followup
Report Date 03/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number388000
Device Lot Number1018034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2021
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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