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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN INF SET QUICK SET 23" 9MM; SET, ADMINISTRATION, INTRAVASCULAR
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UNKNOWN INF SET QUICK SET 23" 9MM; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number UNKNOWN
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
Spontaneous.Pt reports they are currently having trouble changing their tubing.Pt is due to change their cassette but is unable to remove themself from the tubing.Pt reports they are unable to twist the end of the tubing to line up with the arrow on the catheter.Pt has a neighbor over trying to help and states they have tried using pliers without success.Rph contacted cnss who suggested pt try applying a warm compress to the site for about 10 minutes but if that doesn't work, then pt will have to start a new sq site.Pt states they do not know how to do that and does not want to, since they had lots of pain when their current site was started.Rph advised pt was to call pharmacy again if they still cannot remove they tubing and cnss and rph will walk them through starting a new sq site.No interruption in therapy or adverse event reported due to the defective tubing, which is available for return.Defective tubing lot number and expiration date is unknown.No further info, details or dates available.Sq (subcutaneous) remunity pharmacy fill pt (patient).Pt started using remunity device (b)(6) 2024.Reported to (b)(6) by: patient/caregiver.
 
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Brand Name
INF SET QUICK SET 23" 9MM
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
UNKNOWN
MDR Report Key18931466
MDR Text Key338184865
Report NumberMW5152966
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 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Treatment
ADEMPAS.; C-TREPROSTINIL (2.5ML) RM (PAP).
Patient SexFemale
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