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

Model Number	308300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was not performed as there were no discrepancies or abnormalities relevant to the reported complaint.The device was returned for analysis and has been evaluated.A single unused protective plug wing was received.Initial examination of the returned product indicated no abnormalities.Examination of the device after routine removal of the sheath indicated that the catheter hub had become unseated from the introducer.Examination of the position of the catheter tip and the cannula point in this condition revealed that the cannula tip was partly covered.This covering would result in difficult initial penetration in use.The catheter was reseated manually, and it remained seated.Per the instructions for use (ifu), catheters should be reseated prior to use.Given that the catheter hub easily became unseated during sheath removal, it is possible that the user failed to follow the instructions for use prior to using the device.The root cause of the reported complaint was due to user interface.No actions were taken for the primary concern reported.
Event or Problem Description
It was reported that the hub was leaking.No patient injury was reported.

• Brand Name: JELCO PROTECTIV SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• 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: 15699676
• Report Number: 3012307300-2022-26512
• Device Sequence Number: 8221188
• Product Code: FOZ
• UDI-Device Identifier: 10351688071361
• UDI-Public: 10351688071361
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2022

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: 11/13/2020
• Device Model Number: 308300
• Device Catalogue Number: 308300
• Device Lot Number: 3525093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2017
• 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