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

Model Number 306701

Device Problems Mechanical Problem (1384); Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

A picture was received from the customer to demonstrate the reported problem.No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review was not performed because the correct lot number was unknown.No root cause could be determined as the complaint could not be confirmed.No further action was required at this time as the the reported event was not confirmed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that during use, the safety feature button that retracts the intravenous (iv) needle from the catheter failed.Further information indicated that the plastic catheter would not slide off the needle using the guide, which resulted in the nurse having to pull the needle out of the catheter without the needle being retracted.No patient injury was reported.

• Brand Name: PROTECTIV PLUS SAFETY IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15292437
• MDR Text Key: 303241113
• Report Number: 3012307300-2022-16159
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071217
• UDI-Public: 10351688071217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: 306701
• Device Catalogue Number: 306701
• Device Lot Number: 3894989
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1