MAUDE Adverse Event Report: SMITHS MEDICAL ITALIA SRL JELCO SAFETY PROTECTIV PLUS CATHETERS; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	308000
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter hub was very loose and detached easily.The iv catheter was falling off the needle just upon removing the cap.The needle guard did not slide back when pulling back on it, rather it detached from the catheter causing the blood to flow freely and left the needle exposed.Sometimes this happened spontaneously without even pulling back on the needle guard.This had resulted in one needle stick injury.Iv started with a lot of difficulty and was a safety concern.It caused an increased exposure to blood and unprotected needles.There was no patient harm/adverse event reported.
Additional Manufacturer Narrative
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
One new and one opened/unused device was returned, both from lot number 4421018.Analysis of sample one found an inadequate amount of adhesive dispensed on the needle guard nose, allowing the fluid to pass through the annular clearance between the cannula.Analysis of sample two confirmed compliance of the unit with the specifications: the sample passed all the tests with no anomalies noted.A device history review was performed, and no maintenance tickets during the production of the lot involved that would pertain to this issue were found.Review of the complaint database didn¿t find other complaints on the lot involved.Based on the investigation results, the customer¿s allegation is confirmed, but there is no evidence of a systematic issue, rather the defective unit is probably attributable to a temporary issue on the adhesive dispensing station.The defective unit may be considered an isolated occurrence.

• Brand Name: JELCO SAFETY PROTECTIV PLUS CATHETERS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: 21885698
• Report Number: 3012307300-2025-04632
• Device Sequence Number: 17002814
• Product Code: FOZ
• UDI-Device Identifier: 10351688071330
• UDI-Public: (01)10351688071330(17)260721(10)4421018
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 07/21/2026
• Device Catalogue Number: 308000
• Device Lot Number: 4421018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown