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

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.

• Brand Name: PROTECTIV PLUS SAFETY IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, SHORT TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 201 west queen st.; southington CT 06489
• MDR Report Key: 8639904
• MDR Text Key: 146065931
• Report Number: 8639904
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3063
• Device Lot Number: 3777865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15330 DA
• Patient Weight: 104