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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AS LVP 20D DEHP 3SS CV; INTRAVASCULAR ADMINISTRATION SET
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AS LVP 20D DEHP 3SS CV; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2426-0500
Device Problem Backflow (1064)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2021
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 as lvp 20d dehp 3ss cv had issues with the secondary flowing into the primary bag during use.The following information was provided by the initial reporter: "secondary flowed into primary bag.".
 
Event Description
It was reported that the as lvp 20d dehp 3ss cv had issues with the secondary flowing into the primary bag during use.The following information was provided by the initial reporter: "secondary flowed into primary bag".
 
Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.It was reported by the customer that the secondary flowed into primary bag.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2426-0500 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
AS LVP 20D DEHP 3SS CV
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12199817
MDR Text Key262673935
Report Number9616066-2021-51565
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203021006
UDI-Public37613203021006
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2426-0500
Device Catalogue Number2426-0500
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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