MAUDE Adverse Event Report: DELTA MED SPA DELTAVEN FAST FLASH; INTRAVASCULAR IV CATHETER

Model Number	3811473
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
With reference to report fda # (b)(4) we have collected from our warehouse n.3 sterile devices of the same lot of deltaven y dnl g24x19mm batch 11t15311 involved in the incident.I - tests performed on n.3 deltaven y dnl g24x19mm/s batch 11t15311 code 3811473 to verify the conformity of the safety feature against needlesticks injuries.1 - visual inspection of the safety feature aimed at verifying its integrity, completeness and correct assembly of the components that constitute it so that it engages regularly.The control report is available in annex a and the results obtained are indicated therein; 2 - control of the needle ovalization which determines, by interference with the diameter of the hole in the safety spring, the activation of the safety device that covers the tip of the needle.The control report is available in annex b and the results obtained are indicated therein; 3 - dynamometric control of the activation of the safety feature and its detachment from the catheter body from which it is possible to establish whether the safety device has activated regularly at the end of the extraction from the needle.The control report is available in annex c and the results obtained are indicated therein; 4 - safety device efficiency check consists in verifying that even with repeated attempts to remove the tip of the needle from the safety device, this does not let it to come out.The control report is available in annex d and the results obtained are indicated therein.All the results obtained, in reference to the above-mentioned points confirm the suitability of the manufactured devices and the absence of manufacturing defects in the product referred to lot 11t15311.Since the device involved in the incident is not available, it is not possible to establish exactly the cause of the failure to activate the safety device.
Event or Problem Description
I was placing an intravenous line (iv) for my positron emission tomography (pet) rubidium patient and when i got blood return and retracted the needle back, the needle was still exposed and did not lock with the safety feature, leaving the needle exposed, almost poking myself.High safety risk.

• Brand Name: DELTAVEN FAST FLASH
• Common Device Name: INTRAVASCULAR IV CATHETER
• Manufacturer (Section D): DELTA MED SPA; via guido rossa 20; viadana, mantova 46019 ; IT 46019
• Manufacturer (Section G): DELTA MED SPA; via e. segrè 6; sorbolo a levante, reggio emilia 42041 ; IT 42041
• Manufacturer Contact: priscilla tagliaferri ; via guido rossa 20; viadana, mantova 46019 ; IT 46019
• MDR Report Key: 20450747
• Report Number: 3006846316-2024-00001
• Device Sequence Number: 9232131
• Product Code: FOZ
• UDI-Device Identifier: 38032248381149
• UDI-Public: 38032248381149
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/01/2024

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 Model Number: 3811473
• Device Catalogue Number: 3811473
• Device Lot Number: 11T15311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• 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