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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON, S.A. BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515306
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2022
Event Type  malfunction  
Manufacturer Narrative
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 phaseal¿ iv bag/line access devices had flow issues/blockage during infusion.The following information was provided by the client: "difficulties in administering cimevan iv.The infusion has a lot of difficulty in flowing, the chamber of the tube empties completely and then the infusion stops flowing.The chamber has to be refilled manually and the infusion restarted.And this until the end of the bottle.".
 
Event Description
It was reported that the bd phaseal¿ iv bag/line access devices had flow issues/blockage during infusion.The following information was provided by the client: "difficulties in administering cimevan iv.The infusion has a lot of difficulty in flowing, the chamber of the tube empties completely and then the infusion stops flowing.The chamber has to be refilled manually and the infusion restarted.And this until the end of the bottle.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 18-apr-2022.H6: investigation summary: one sample was provided to our quality team for investigation.Through visual inspection, no damage or defects were observed that could have contributed to the reported incident.Functional testing was performed, attempting to pass liquid through the fluid channel and it was found the channel was blocked.After clearing the channel, a flow test was performed and liquid was able to successfully move through the device without issue.Characterization testing was performed on the substance found to be blocking the channel and identified it was calcified drug that was used with the device.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including flow rate verification.As the lot involved in this incident is unknown, a device history review could not be performed.Based on the sample evaluation, the root cause of this incident is related to calcification of the drug, blocking proper flow of fluid.
 
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Brand Name
BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP   22520
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14167904
MDR Text Key289757889
Report Number3003152976-2022-00162
Device Sequence Number1
Product Code ONB
UDI-Device Identifier00382905153068
UDI-Public0100382905153068
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K123213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515306
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/13/2022
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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