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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 Problems Complete Blockage (1094); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2021
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown.(b)(6).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 2ss cv experienced flow issues.The following information was provided by the initial reporter: at end of infusion; rn clamped line and ensured ns line was open, when rn returned to the room the ns flush had back flowed into the clamped mesna bag.Rn unclamped the mesna line and clamped the ns line in order to flush tubing.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 9/8/2021 h.6.Investigation: sample arrived on 9/8 that was meant for this pr was misplaced and is unable to be located.The customer complaint that when rn returned to the room the ns flush had back flowed into the clamped mesna bag could not be verified due to the product being inadvertently misplaced for failure investigation.If the sample is found the investigation will be reopened.A device history record review could not be performed on model 2420-0007 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.
 
Event Description
It was reported that the as lvp 20d 2ss cv experienced flow issues.The following information was provided by the initial reporter: at end of infusion; rn clamped line and ensured ns line was open, when rn returned to the room the ns flush had back flowed into the clamped mesna bag.Rn unclamped the mesna line and clamped the ns line in order to flush tubing.
 
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Brand Name
AS LVP 20D 2SS CV
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12547350
MDR Text Key273811170
Report Number9616066-2021-52138
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 other,user facility
Type of Report Initial,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? No
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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