MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. CARR-LOCKE INJECTION NEEDLE; BIOPSY NEEDLE

Catalog Number 00711811

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2020

Event Type  malfunction  

Event Description

During the case, the scrub tech attempted to use the needle and the needle would not push out of the catheter when she was trying to prime the needle.Fda safety report id# (b)(4).

• Brand Name: CARR-LOCKE INJECTION NEEDLE
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC. ; mentor OH 44060
• MDR Report Key: 10217599
• MDR Text Key: 197318774
• Report Number: MW5095298
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: 00711811
• Device Lot Number: 1914944
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 84