MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; MOD KIT PULSET 3CC SYRINGE 23G X 1" SAFETY TIP 25U BH

Model Number	ABGKT3CC23G-REG
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is potential contamination to patient and clinician.This would cause for the process to be repeated.
Event or Problem Description
Leaking from the needle. .
Additional Manufacturer Narrative
There is potential contamination to patient and clinician.This would cause for the process to be repeated.Summary: initial complaint was confirmed that blood could leak from needle of abg devices.Attempts to replicate failure mode indicated that dropping the device or pushing the rod/plunger assembly could cause fluid to leak from the syringe/needle assembly.Further conversations with customer indicated the customer does not prefer the device supplied by sunmed and mishandling of the device may be occurring as a cause of the leaks.Ra: rma-20036 risk id r78: clinician exposure to blood; s=8.
Event or Problem Description
Leaking from the needle. .

• Brand Name: WESTMED LLC
• Common Device Name: MOD KIT PULSET 3CC SYRINGE 23G X 1" SAFETY TIP 25U BH
• 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: 16482056
• Report Number: 2028807-2023-00004
• Device Sequence Number: 5063865
• Product Code: CBT
• UDI-Device Identifier: 00326053118616
• UDI-Public: 00326053118616
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 03/03/2023

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: ABGKT3CC23G-REG
• Device Catalogue Number: ABGKT3CC23G-REG
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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