MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; 3ML A-LINE ASPIRATING LUER SLIP SYRINGE, 50IU(~16.7IU/ML) BALANCED HEPARIN

Model Number	11561346
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The loose plunger or cap could cause the blood to drain or splash from the filter cap or plunger of the syringe.The user's face being splashed by the blood draw causing an exposure to contamination for the patient and clinician.This would cause the process to be repeated.
Event or Problem Description
Customer is concerned that blood can drain/splash from either the filter cap or the plunger of the syringe.In addition, the plunger may be so loose that it comes off the syringe completely, causing the blood to naturally flow out of the syringe.
Additional Manufacturer Narrative
The loose plunger or cap could cause the blood to drain or splash from the filter cap or plunger of the syringe.The user's face being splashed by the blood draw causing an exposure to contamination for the patient and clinician.This would cause the process to be repeated.Root cause investigation during a visit to the end user's facility identifies that the customer/end-user was recently converted to airlife products for abg devices from an alternate supplier.The alternate supplier allowed for a much higher air flow through the vented tip cap assembly with a different design than airlife devices.As a result, the end users are over-exerting pressure on the filter cap leading to excessive pressures that dislodge the cap from the syringe.Additionally, the end users handle the syringes in a manner that allows the filter to close sooner than anticipated.
Event or Problem Description
Customer is concerned that blood can drain/splash from either the filter cap or the plunger of the syringe.In addition, the plunger may be so loose that it comes off the syringe completely, causing the blood to naturally flow out of the syringe.

• Brand Name: WESTMED LLC
• Common Device Name: 3ML A-LINE ASPIRATING LUER SLIP SYRINGE, 50IU(~16.7IU/ML) BALANCED HEPARIN
• 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: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18540635
• Report Number: 2028807-2024-00001
• Device Sequence Number: 7923346
• Product Code: CBT
• UDI-Device Identifier: 00709078013409
• UDI-Public: 00709078013409
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: 11561346
• Device Catalogue Number: 11561346
• Device Lot Number: 403631
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 04/03/2024
• 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