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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ULTRASITE 2 WAY CAPLESS VAL; SET, ADMINISTRATION, INTRAVASCULAR
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B. BRAUN MEDICAL INC. ULTRASITE 2 WAY CAPLESS VAL; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Fluid/Blood Leak (1250); Inaccurate Delivery (2339)
Patient Problems Nausea (1970); Dizziness (2194)
Event Date 04/01/2022
Event Type  Injury  
Event Description
Spontaneous.Patient's mother reports that for the third time this week the ultra site 2 way capless connector has leaked; no dates or product lot number provided.Last night ((b)(6) 2022) the ultra site 2 way capless connector leaked again; patient was not getting medication, pajamas were wet and was blood backing up in line.Patients mother changed everything out and restarted veletri at full dose.Patient had nausea and dizziness but symptoms subsided.Pharmacy to dispense the invision plus connectors to replace the ultra site 2 way capless connectors.No further info, details or dates available.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? yes; if yes, was any medical intervention provided?no; is the actual product available for investigation? no; did we [mfr] replace the product? yes, but with different connector; did the pt have add'l product they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes; what is the outcome of the event? resolved.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
ULTRASITE 2 WAY CAPLESS VAL
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
MDR Report Key14102963
MDR Text Key289318517
Report NumberMW5108932
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Treatment
VELETRI
Patient Age22 YR
Patient SexFemale
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