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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PROTECTIV PLUS SAFETY IV CATHETER CATHETER, INTRAVASCULAR, SHORT TERM

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SMITHS MEDICAL ASD, INC PROTECTIV PLUS SAFETY IV CATHETER CATHETER, INTRAVASCULAR, SHORT TERM Back to Search Results
Catalog Number 3063
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2019
Event Type  malfunction  
Event Description
Nurse was starting iv on patient using a 24g protectiv plus angiocath. After cannulating the vein and engaging the safety device to retract the needle she attempted to disconnect the stylet from the catheter. When she did this the tip of the stylet broke off inside the catheter leaving the soiled needle tip exposed. The rn was unable to remove the plastic piece and the iv catheter had to the be removed and the patient recannulated.
 
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Brand NamePROTECTIV PLUS SAFETY IV CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, SHORT TERM
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
201 west queen st.
southington CT 06489
MDR Report Key8639904
MDR Text Key146065931
Report Number8639904
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3063
Device Lot Number3777865
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/17/2019
Event Location Outpatient Treatment Facility
Date Report to Manufacturer05/24/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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