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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IV EXTN SET 12" MICROBORE; SET, ADMINISTRATION, INTRAVASCULAR

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IV EXTN SET 12" MICROBORE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Crack (1135)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
Per many from md office, patient was in the er who is on iv veletri via picc line.She has visited the er twice in the last 3 days for cracked clave connectors.She received these in her last shipment and suspects they are faulty.She is also asking for additional extensions as she has a picc line and can¿s reach the connection without it, lot number is unknown.Unknown no missed dose.Unknown if patient has the defective product hand for possible return to the manufacturer.No further information provided all known information is contained in this report.Veletri directions: reconstitute contents of vial with 5 ml diluent and mix cassette as directed.Infuse continuously per md orders.Dose range: 1-150 ng per kg per min.Reported to (b)(6) by: health professional.
 
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Brand Name
IV EXTN SET 12" MICROBORE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key14624096
MDR Text Key293648563
Report NumberMW5110159
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/06/2022
Patient Sequence Number1
Patient SexFemale
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