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

Model Number	306701
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product sample was received; therefore, visual and functional testing could not be performed.A device history review (dhr) was performed, and found nonconformance data identified.There was one in-process nonconformance potentially related to this event that was screened 100 percent; however, the nonconforming product was from totes not included in this lot.As no product was returned for investigation, no root cause could be determined as the complaint could not be confirmed.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that there were issues with trying to thread the catheter off the stylet and it would not retract.No patient injury was reported.

• Brand Name: PROTECTIV PLUS SAFETY I.V. CATHETERS
• 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: 15301161
• Report Number: 3012307300-2022-16366
• Device Sequence Number: 7222815
• Product Code: FOZ
• UDI-Device Identifier: 10351688071217
• UDI-Public: 10351688071217
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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: 05/29/2022
• Device Model Number: 306701
• Device Catalogue Number: 306701
• Device Lot Number: 3828857
• 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: 07/11/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2019
• 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