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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION ADAPTER C100; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION ADAPTER C100; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515306
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2019
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 air was in the bd phaseal¿ infusion adapter c100 line during use.Additionally, the drip chamber was reportedly "1/2" full when the infusion began.The following information was provided by the initial reporter: "customer had air in line before all fluid from the fk bag was infused and they were using the 515306.They said that the drip chamber was filled 1/2 full when the infusion began.".
 
Manufacturer Narrative
Investigation: two photos were provided to our quality team for investigation.The photos show a vented iv line being used during the infusion and bubbles are visible in the tubing and infusion bag.As the lot involved in this incident is unknown, a device history review could not be performed.Per the instructions for use included with the product, phaseal c100 should not be used with vented iv tubing or an open vent as this could create a negative pressure which can add air the infusion bag leading to the air bubbles seen in the line, as well as the potential for exposure to hazardous medications.It is important to follow the instructions for use when using phaseal devices to ensure the product functions as intended.Based on the results of our investigation, our manufacturing process did not contribute to the reported malfunction.
 
Event Description
It was reported that air was in the bd phaseal¿ infusion adapter c100 line during use.Additionally, the drip chamber was reportedly "1/2" full when the infusion began.The following information was provided by the initial reporter: "customer had air in line before all fluid from the fk bag was infused and they were using the 515306.They said that the drip chamber was filled 1/2 full when the infusion began.".
 
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Brand Name
BD PHASEAL¿ INFUSION ADAPTER C100
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key8945181
MDR Text Key156126365
Report Number3003152976-2019-00595
Device Sequence Number1
Product Code ONB
UDI-Device Identifier00382905153068
UDI-Public00382905153068
Combination Product (y/n)N
PMA/PMN Number
K123213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 10/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515306
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received08/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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