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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 Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/22/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.The customer complaint of damage component - no leak could not be verified due to the product not being returned for failure investigation.A device history record review for model 2426-0500 lot number 21033424 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 31mar2021.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.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that as lvp 20d dehp 3ss cv was damaged, but still operable.The following information was provided by the initial reporter: "it was reported by the customer that the tubing is not properly attach to the connector.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-30.Investigation summary one sample was received for quality investigation.The customer complaint of damaged component - no leak was verified by visual inspection.Evaluation of the sample received revealed that the silicone tubing of the pumping segment was damaged at the location that it would normally be connected to the upper pumping segment fitting.In addition, the blue fitment collar was not submitted with the sample received, but the fitment collar might have been attached on the tip of the silicone tubing because there is an indention at the end of the silicone tubing similar to the indention seen on the silicone tubing on correctly assembled infusion sets.A device history record review for model 2426-0500 lot number 21033424 was performed.The search showed that a total of (b)(4)units in 1 lot number was built on 31mar2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue seen in this complaint is the misalignment of the assembly apparatus at the manufacturing facility.This issue has been seen in previous investigations when the tubing and tubing collar are not aligned correctly before joining the silicone tubing to the upper pumping segment fitting.The misalignment causes the tubing and tubing collar to fall off the upper pumping segment fitting without much effort exerted on the infusion set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
 
Event Description
It was reported that as lvp 20d dehp 3ss cv was damaged, but still operable.The following information was provided by the initial reporter: "it was reported by the customer that the tubing is not properly attach to the connector.".
 
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Brand Name
AS LVP 20D DEHP 3SS CV
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12502582
MDR Text Key272462023
Report Number9616066-2021-52087
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 10/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2024
Device Model Number2426-0500
Device Catalogue Number2426-0500
Device Lot Number21033424
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2021
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2021
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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