MAUDE Adverse Event Report: FLOSWITCH HP; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	39215
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.
Event or Problem 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.
Additional 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 or Problem 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.

• Brand Name: FLOSWITCH HP
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10750150
• Report Number: 2134265-2020-14755
• Device Sequence Number: 3061167
• Product Code: DQO
• UDI-Device Identifier: 08714729049746
• UDI-Public: 08714729049746
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K913871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2025
• Device Model Number: 39215
• Device Catalogue Number: 39215
• Device Lot Number: 0025943051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/16/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1