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

Model Number	306701
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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).

• Brand Name: PROTECTIV PLUS SAFETY IV CATHETER
• Common Device Name: 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: 15292386
• Report Number: 3012307300-2022-16157
• Device Sequence Number: 7167196
• Product Code: FOZ
• UDI-Device Identifier: 10351688071217
• UDI-Public: 10351688071217
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown