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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM; SET, IV FLUID TRANSFER
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BECTON DICKINSON BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM; SET, IV FLUID TRANSFER Back to Search Results
Catalog Number MV0513-0006
Device Problems Partial Blockage (1065); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2022
Event Type  malfunction  
Manufacturer Narrative
Oem manufacture: 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.Medical device lot #: an invalid lot # of 212048 was provided by the initial reporter device expiration date: unknown.Initial reporter facility name: (b)(6).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¿ vialshield closed vial access device, 13 mm experienced flow issues, and leakage.The following information was provided by the initial reporter: taxol filter gummed up the 2nd time i put it on.Tried pumping to loosen filter.Did not loosen.In the end, too much pressure in the ampoule due to pumping, and then liquid leaked into the balloon.
 
Event Description
It was reported that the bd smartsite¿ vialshield closed vial access device, 13 mm experienced flow issues, and leakage.The following information was provided by the initial reporter: taxol filter gummed up the 2nd time i put it on.Tried pumping to loosen filter.Did not loosen.In the end, too much pressure in the ampoule due to pumping, and then liquid leaked into the balloon.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 22-mar-2022.Investigation summary one mv0513-0006 sample from lot 212048 was received without packaging for investigation.The sample was received with residual fluid in the device and was received connected to a vial containing residual medication.A visual inspection of the returned sample identified that the spike of the vial access device (vad) had fully penetrated the septum of the vial.The mv0513-0006 sample was then detached from the vial and subjected to functional testing using a 50ml bd plastipak syringe from bd stock; no occlusions were observed throughout testing.The vial was then reattached to the vad and subjected to functional testing; again no occlusions or flow restrictions were observed throughout testing with fluid able to be flushed into and aspirated from the vial.A visual inspection of the vial identified that the septum had been accessed through the center circle of the vial septum and no damage or defects were observed to the vad which may have contributed to the customer's experience.The details of this feedback were shared with the legal manufacturer of the product, yukon medical llc, for investigation.A review of the production records for lot 212048 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the root cause of the customer¿s experience in this instance.Testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.A review of the customer feedback database indicates that this is a rare occurrence with this customer being the only customer to provide this type of feedback against the mv0513-0006 product in the past 12 months.
 
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Brand Name
BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM
Type of Device
SET, IV FLUID TRANSFER
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13588549
MDR Text Key287597735
Report Number2243072-2022-00264
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Reporter Country CodeSZ
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 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMV0513-0006
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
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
Patient Sequence Number1
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