MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; WESTMED LLC1ML VENTED LUER SLIP SYRINGE, 25IU/ML BALANCED HEPARIN

Model Number	79720
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportable, as this would contaminate the sample and cause a re-draw.
Event or Problem Description
The customer has noted multiple issues with the syringes: 1.The syringe doesn't always fill properly.2.When aspirating, air gets into the sample (although they did state that this often happens with self-filling syringes).3.Blood also comes through the cap (blood dripped through the cap).4.Blood has sometimes also flowed through the plunger of the syringe.
Additional Manufacturer Narrative
Reportable, as this would contaminate the sample and cause a re-draw.Product complaint not confirmed with images or returned product; test report r-21-0165-dv identifies worst-case condition sampling that the filter material is able to meet iso 7886-1:2017 requirements.Ra: rma-20036b risk id r21 identifies risk associated with filter material failure and clinician blood exposure.
Event or Problem Description
The customer has noted multiple issues with the syringes: the syringe doesn't always fill properly.When aspirating, air gets into the sample (although they did state that this often happens with self-filling syringes).Blood also comes through the cap (blood dripped through the cap).Blood has sometimes also flowed through the plunger of the syringe.

• Brand Name: WESTMED LLC
• Common Device Name: WESTMED LLC1ML VENTED LUER SLIP SYRINGE, 25IU/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: 16779154
• Report Number: 2028807-2023-00012
• Device Sequence Number: 12516136
• Product Code: CBT
• UDI-Device Identifier: 00709078013287
• UDI-Public: 00709078013287
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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: 79720
• Device Catalogue Number: 11561340
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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