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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AS LVP 20D DEHP 2SS CV INTRAVASCULAR ADMINISTRATION SET

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AS LVP 20D DEHP 2SS CV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2420-0500
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: a complaint of sets cracking at the port was received from the customer. A used sample was returned for investigation. The set was visually inspected for any damages or defects. No cracks could be seen on the set. The set was then primed with no signs of leakage. The set was then infused at a rate of 125 ml/hr and there was an air in line alarm. The set was then reprimed and air bubbles were removed from the first y-site. After this the set was reinfused at 125 ml/hr and there were no issues. The defect could not be confirmed. A device history record review could not be performed on model 2420-0500 because a lot number was not provided by the customer. A root cause for the customers complaint of component damage could not be determined as the defect could not be confirmed. 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 5 as lvp 20d dehp 2ss cv sets were cracked at the port. The following information was provided by the initial reporter: "i have one of the sets in a bag. Icu has reported 5 or more, where they are cracking at the port. ".
 
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Brand NameAS LVP 20D DEHP 2SS CV
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
MDR Report Key12453298
MDR Text Key270836984
Report Number9616066-2021-52003
Device Sequence Number1
Product Code FPA
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
Report Date 08/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2420-0500
Device Catalogue Number2420-0500
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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