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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ SECONDARY SET DRIP CHAMBER C60; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON, S.A. BD PHASEAL¿ SECONDARY SET DRIP CHAMBER C60; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515301
Device Problems Break (1069); Fluid/Blood Leak (1250)
Patient Problems Injury (2348); Chemical Exposure (2570)
Event Date 12/05/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.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¿ secondary set drip chamber c60 disconnected from the iv tubing and the connector port broke off multiple times, which caused chemotherapy drug leakage "with each incident".It was also reported there was "patient harm" known to have occurred.However, there was no report of medical intervention.
 
Event Description
It was reported that the bd phaseal¿ secondary set drip chamber c60 disconnected from the iv tubing and the connector port broke off multiple times, which caused chemotherapy drug leakage "with each incident".It was also reported there was "patient harm" known to have occurred.However, there was no report of medical intervention.
 
Manufacturer Narrative
Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.As there is no lot retained samples cannot be taken for investigation.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
BD PHASEAL¿ SECONDARY SET DRIP CHAMBER C60
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key8186327
MDR Text Key131127920
Report Number3003152976-2018-00555
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
PMA/PMN Number
K123213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515301
Device Lot NumberUNKNOWN
Date Manufacturer Received12/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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