MAUDE Adverse Event Report: WESTMED LLC ATELLICA VTR SYRINGE; 1ML A-LINE ASPIRATING LUER SLIP SYRINGE

Model Number	11561341
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 21 nov 2024 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 splattered into an operator's eye while expelling air from an atellica vtr syringe; there was no reported injury.Additionally, it was noted the patients blood was known to contain blood borne pathogens and testing continues for blood borne pathogens and relevant treatment thereafter.The current condition of the operator was not reported.
Event or Problem Description
It was reported, blood splattered into an operator's eye while expelling air from an atellica vtr syringe; there was no reported injury.Additionally, it was noted the patients blood was known to contain blood borne pathogens and testing continues for blood borne pathogens and relevant treatment thereafter.The current condition of the operator was not reported.
Additional Manufacturer Narrative
The actual sample from the reported event was not returned for evaluation.The device history record for lot 062222n25 was reviewed and the product was produced according to product specifications.The reported event could not be confirmed as reported; the root cause is undetermined.All information reasonably known as of 20 jan 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.

• Brand Name: ATELLICA VTR SYRINGE
• Common Device Name: 1ML A-LINE ASPIRATING LUER SLIP SYRINGE
• 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 ; 2054826767
• MDR Report Key: 20753887
• Report Number: 2028807-2024-00070
• Device Sequence Number: 12867303
• Product Code: CBT
• UDI-Device Identifier: 00709078013362
• UDI-Public: (01)00709078013362(10)062222N25(11)220203
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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: 02/03/2025
• Device Model Number: 11561341
• Device Lot Number: 062222N25
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown