MAUDE Adverse Event Report: WESTMED LLC ATELLICA VTR SYRINGES; 3ML VENTED LUER SLIP SYRINGE, (50IU)16.7IU/ML BALANCED HEPARIN, VENTED TIP CAP

Model Number	11561344
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: na investigation conclusion: d4; h6 the product involved in the report has not been returned for evaluation; additionally, no photos or video evidence were provided.Without a sample to perform functional evaluation or photographic /video evidence the root cause could not be determined.The device history record for lot 403650 was reviewed and the product was produced according to product specifications.A risk assessment was performed, and the ultimate risk was determined to be low.All information reasonably known as of 03 jul 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported, blood splashed onto a nurse's face and arms while pushing blood into a 3cc-50u vented & vented tip cap ls syringe.There was no reported injury.Additional information received on 04apr2025 reported, there was no evidence of damage to the syringe; the blood splash occurred when an attempt to vent the syringe was performed.It was additionally reported, the syringe 'looked normal'.There was no reported injury.

• Brand Name: ATELLICA VTR SYRINGES
• Common Device Name: 3ML VENTED LUER SLIP SYRINGE, (50IU)16.7IU/ML BALANCED HEPARIN, VENTED TIP CAP
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 22398577
• Report Number: 2028807-2025-00016
• Device Sequence Number: 4901815
• Product Code: CBT
• UDI-Device Identifier: 00709078013362
• UDI-Public: (01)00709078013362(10)403650(17)260116(11)230116
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K822786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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: 01/16/2026
• Device Model Number: 11561344
• Device Lot Number: 403650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown