MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; PULSET 3CC SYRINGE 22G X 1" SAFETY TIP 25U BH, VENTED LUER TIP CAP

Model Number	3302-91VT
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportable as it is causing blood exposure to the clinician.
Event or Problem Description
Tip of the cap broke off after the purge of the syringe.This has caused a datex issue where a user has been covered in blood.
Event or Problem Description
Tip of the cap broke off after the purge of the syringe.This has caused a datex issue where a user has been covered in blood.
Additional Manufacturer Narrative
Reportable as it is causing blood exposure to the clinician.Summary: tm-499 contains the inspection requirements for weld strength and leaks.Complaint history investigation identifies this as the only complaint for more than 1.5million devices sold with vented luer tip caps in 2022.Carb review after 5/8/2023.Ra: rma-20036a identifies risk id# r21 with foreseeable hazard "blood passes through vent filter after contact with cmc material" and cause "blood exposure to clinician" with associated severity of 8.

• Brand Name: WESTMED LLC
• Common Device Name: PULSET 3CC SYRINGE 22G X 1" SAFETY TIP 25U BH, VENTED LUER 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: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 16696606
• Report Number: 2028807-2023-00006
• Device Sequence Number: 3677371
• Product Code: CBT
• UDI-Device Identifier: 00709078007798
• UDI-Public: 00709078007798
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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: 3302-91VT
• Device Catalogue Number: 3302-91VT
• Device Lot Number: 092321N41
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/10/2023
• 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