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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD SMARTSITE¿ VENTED VAD-MULTIPACK INFUSION SET INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON BD SMARTSITE¿ VENTED VAD-MULTIPACK INFUSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MV042005-0006
Device Problems Complete Blockage (1094); Restricted Flow rate (1248)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is (b)(4). This site is an oem manufacturing site. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. The reported lot# 212009 was not found for the reported catalog# mv042005-0006. 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.
 
Event Description
It was reported that the bd smartsite¿ vented vad-multipack infusion set was unable to withdraw liquid from the paclitaxel vial after spiking it and connecting a syringe. The following information was provided by the initial reporter, translated from french to english: "positioning the spike on a paclitaxel vial, after connecting a syringe, unable to withdraw the liquid. Impossibility to push the plunger to inject air. Spike correctly positioned, which hit the septum well. No consequences for the operator or the patient conservative measures and actions taken: quarantined the vial and device. Use of a new vial and spike. ".
 
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Brand NameBD SMARTSITE¿ VENTED VAD-MULTIPACK INFUSION SET
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 Key12693156
MDR Text Key278441234
Report Number2243072-2021-02584
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
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 11/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMV042005-0006
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? Yes
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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