MAUDE Adverse Event Report: SMITHS MEDICAL ITALIA SRL JELCO SAFETY PROTECTIV PLUS CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Catalog Number	308600
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gripper pads were pulled back and the device was stuck and won't allow the needle retraction into the needle guard.In this instance when the clinician pulled the needle guard out of the hub, a majority of needle was exposed.At that point it was impossible to pull the needle into the needle guard.The issue happened during use with a patient.There was patient involvement and there was no patient harm.
Additional Manufacturer Narrative
B3: day of event is unknown.H3: device not received by manufacturer. a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
No device or device photo was returned for investigation.Functional and visual testing could not be performed and no confirmation due to no device returned.Due to this, no root cause was determined.The device history review of the reported lot number found no non-conformities during the manufacturing process.

• Brand Name: JELCO SAFETY PROTECTIV PLUS CATHETERS
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ITALIA SRL; via della stazione, 2; latina scalo ; IT
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19361818
• Report Number: 3004187702-2024-00008
• Device Sequence Number: 3785413
• Product Code: FOZ
• UDI-Device Identifier: 10351688071316
• UDI-Public: (01)10351688071316(17)260915(10)4432097
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: 09/15/2026
• Device Catalogue Number: 308600
• Device Lot Number: 4432097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown