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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AS LVP 20D 2SS CV; INTRAVASCULAR ADMINISTRATION SET
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AS LVP 20D 2SS CV; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2420-0007
Device Problem Backflow (1064)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/10/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the as lvp 20d 2ss cv back-flowed chemo medication from the secondary bag into the primary during the infusion.The following information was provided by the initial reporter: "chemo medication backflowed from secondary bag to primary bag during chemo secondary infusion".
 
Event Description
It was reported that the as lvp 20d 2ss cv back-flowed chemo medication from the secondary bag into the primary during the infusion.The following information was provided by the initial reporter: "chemo medication backflowed from secondary bag to primary bag during chemo secondary infusion".
 
Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.It was reported that chemo medication back flowed from secondary bag to primary during chemo secondary infusion.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 2420-0007 lot number 21035088 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - back flow with lot #21035088 regarding item #2420-0007.
 
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Brand Name
AS LVP 20D 2SS CV
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12256783
MDR Text Key264509904
Report Number9616066-2021-51675
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203021020
UDI-Public37613203021020
Combination Product (y/n)N
PMA/PMN Number
K944320
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 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/01/2024
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number21035088
Was Device Available for Evaluation? No
Date Manufacturer Received08/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2021
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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