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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: syringe.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 26 novt 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by sunmed 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 sunmed holdings llc.Sunmed 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 sunmed holdings complaint database and is 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 a sunmed holdings llc.Product is defective or causes serious injury.Airlife's investigation findings states that "the complaint of "after removing air bubbles blood was leaking through the filter cap and hit the patient's arm" regarding part: 11561344 was not confirmed.The root cause could possibly be that the vent had no cmc material present on the filter.A risk assessment was performed, and the ultimate risk was determined to be low which does require reporting to the capa review board.There have been 2 other complaints regarding the same part and a similar issue within the 24 months preceding the reporting of this issue.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends".
Event or Problem Description
It was reported that "the issue occurred where after removing air bubbles blood was leaking through the filter cap and hit the patient's arm".
Additional Manufacturer Narrative
H6: syringe.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 26 novt 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by sunmed 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 sunmed holdings llc.Sunmed 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 sunmed holdings complaint database and is 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 a sunmed holdings llc.Product is defective or causes serious injury.
Event or Problem Description
It was reported that "the issue occurred where after removing air bubbles blood was leaking through the filter cap and hit the patient's arm".

• 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 JAVID DE MEXICO, S.A. DE C.V; carretera internacional km 6.5; edif 18; parque industrial nog; nogales sonora, mexico 84094 ; MX 84094
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 20793061
• Report Number: 2028807-2024-00075
• Device Sequence Number: 15406053
• Product Code: CBT
• UDI-Device Identifier: 00709078013362
• UDI-Public: (01)00709078013362(10)080422N91
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K822786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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 Model Number: 11561344
• Device Catalogue Number: 11561344
• Device Lot Number: 080422N91
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown