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

Model Number	00711811
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: INJECTION NEEDLE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 9155747
• Report Number: 1528319-2019-00036
• Device Sequence Number: 19361511
• Product Code: FCG
• UDI-Device Identifier: 00816765011898
• UDI-Public: (01)00816765011898
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K971842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1