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

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	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following insertion of an iv catheter, iv was noted to be leaking from where the hub of the iv connects to the cannula.The iv had to be removed.No apparent harm to the patient.No other information has been provided at this time.
Additional Manufacturer Narrative
Other text: a device history record (dhr) investigation suggests that the defective sample consists in an isolated occurrence caused by a temporary misalignment of the assembly station.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection confirmed the catheter tube was damaged in proximity of the hub, thus causing the leakage.Functional testing found leakage.The root cause of the reported issue was found to be manufacturing.No corrective action will be implemented at this moment; however, we will monitor the recurrence of this type of defect and if a trend will be identified, a corrective action will be recommended.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-10101.The report was submitted in error.

• Brand Name: JELCO PROTECTIV 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): NULL; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; seventh street plaza; minneapolis, MN 55442
• MDR Report Key: 14547573
• Report Number: 3012307300-2022-10101
• Device Sequence Number: 5171993
• Product Code: FOZ
• UDI-Device Identifier: 10351688071361
• UDI-Public: 10351688071361
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2023

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
• Device Expiration Date: 02/16/2025
• Device Model Number: 308300
• Device Catalogue Number: 308300
• Device Lot Number: 4227310
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/19/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 06/30/2022; 05/09/2023
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/26/2022; 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown