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

Model Number 00711811

Device Problem Defective Component (2292)

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

Event Date 04/27/2019

Event Type  malfunction  

Manufacturer Narrative

Us endoscopy requested the device subject of the reported event be returned for evaluation, which confirmed the report of non-functional locking mechanism.The device history record was reviewed and found no noted nonconformities related to the luer lock mechanism.There have been no other complaints associated with this lot.No additional issues have been reported.

Event Description

Us endoscopy received user facility medwatch #(b)(4) reporting that during a patient procedure the locking feature on their carr-lock injection needle could not be engaged.The function of the locking feature is to maintain the needle in an extended position.The user manually extended the needle and was able to successfully complete the procedure with the same device.There was no report of harm to the patient or user.

• Brand Name: CARR-LOCKE INJECTION NEEDLE
• Type of Device: INJECTION NEEDLE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, OH 44060 ; 4403586251
• MDR Report Key: 9155747
• MDR Text Key: 189591031
• Report Number: 1528319-2019-00036
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00816765011898
• UDI-Public: (01)00816765011898
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2022
• Device Model Number: 00711811
• Device Catalogue Number: 00711811
• Device Lot Number: 1900285
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2019
• 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