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

Model Number ABGKT3CC23G-REG

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Manufacturer Narrative

There is potential contamination to patient and clinician.This would cause for the process to be repeated.

Event Description

Leaking from the needle. .

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 Description

Leaking from the needle. .

• Brand Name: WESTMED LLC
• Type of Device: 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
• MDR Text Key: 310697422
• Report Number: 2028807-2023-00004
• Device Sequence Number: 1
• Product Code: CBT
• UDI-Device Identifier: 00326053118616
• UDI-Public: 00326053118616
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other