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

Model Number 3373-91

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

There is potential contamination to patient and clinician.This would cause for the process to be repeated.Base on the reported information the criteria for reporting an adverse event has been met.

Event Description

Syringe with a hole in the side.Squirted blood on patient and clinician.Delay in treatment and possible blood contamination.

Event Description

Syringe with a hole in the side.Squirted blood on patient and clinician.Delay in treatment and possible blood contamination.

Manufacturer Narrative

There is potential contamination to patient and clinician.This would cause for the process to be repeated.Base on the reported information the criteria for reporting an adverse event has been met.Summary: no other complaints found for prior year.Unable to recreate or confirm complaint via product testing.Ra: (b)(4).

• Brand Name: WESTMED LLC
• Type of Device: FULL KIT PULSET 3CC SYRINGE 23G X 1" SAFETY TIP 25U BH
• Manufacturer (Section D): WESTMED; 5580 s nogales highway; tuscan AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscan AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 14161512
• MDR Text Key: 298955235
• Report Number: 2028807-2022-00010
• Device Sequence Number: 1
• Product Code: CBT
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3373-91
• Device Lot Number: 101221N11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other