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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOSWITCH HP; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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FLOSWITCH HP; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 39215
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.
 
Event Description
It was reported that the accessory failed to secure the seal of the device.A floswitch hp was selected for use.During the course of the procedure, it was noted that the floswitch failed to secure a seal.Furthermore, in the off/closed position of the device, it still pulled air.No patient complications were reported.
 
Manufacturer Narrative
B3 date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.An unopened box of 10 units was returned with no damage to the box and trays observed.Three other units were returned in an opened box.A visual inspection of the three units revealed all parts were assembled correctly.The female and male luers were in good condition and no damage was noted.A functional inspection revealed that the on/off bottom movement on each was normal with no resistance felt.
 
Event Description
It was reported that the accessory failed to secure the seal of the device.A floswitch hp was selected for use.During the course of the procedure, it was noted that the floswitch failed to secure a seal.Furthermore, in the off/closed position of the device, it still pulled air.No patient complications were reported.
 
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Brand Name
FLOSWITCH HP
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
MDR Report Key10750150
MDR Text Key213659813
Report Number2134265-2020-14755
Device Sequence Number1
Product Code DQO
UDI-Device Identifier08714729049746
UDI-Public08714729049746
Combination Product (y/n)N
PMA/PMN Number
K913871
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number39215
Device Catalogue Number39215
Device Lot Number0025943051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2020
Date Manufacturer Received12/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2020
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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