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

Model Number	11561345
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report was discarded and is not available for return.A review of the device history record is in-progress.All information reasonably known as of 18 dec 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 leaked while expressing air, and splashed out from the top of the cap onto the operator's face.It was additionally reported, the operator was wearing gloves and goggles and followed the hospital guidelines for blood exposure.While investigating the event, it was found that the affected syringe was missing the white filter of the tip cap.There was no report of a delay in therapy, hurt, harm or injury as a result of this reported event.
Additional Manufacturer Narrative
Correction: a1.Additional information-investigation completion: d4; h2; h5; h6.The actual complaint product was not available to be returned for evaluation; additionally, no photographic/videographic evidence was provided by the reporter.In the absence of a photo or video, the complaint could not confirmed; without a sample to perform functional evaluation, a root cause could not be determined.The device history record for lot 405075 was reviewed and the product was produced according to product specifications.All information reasonably known as of 26 feb 2026 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 complaint-(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 leaked while expressing air, and splashed out from the top of the cap onto the operator's face.It was additionally reported, the operator was wearing gloves and goggles and followed the hospital guidelines for blood exposure.While investigating the event, it was found that the affected syringe was missing the white filter of the tip cap.There was no report of a delay in therapy, hurt, harm or injury as a result of this reported event.

• Brand Name: ATELLICA VTR SYRINGES
• Common Device Name: 3ML VENTED LUER LOCK 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
• MDR Report Key: 23844120
• Report Number: 2028807-2025-00031
• Device Sequence Number: 21339677
• Product Code: CBT
• UDI-Device Identifier: 00709078013386
• UDI-Public: (01)00709078013386(10)405075(11)230120(17)260120
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: 01/20/2026
• Device Model Number: 11561345
• Device Lot Number: 405075
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2023
• 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