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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow up with the user facility, us endoscopy learned that the needle subject of the event was replaced by an identical device.The procedure was successfully completed.The user facility did not retain the device of the subject event therefore, a full investigation of the reported event is not possible.The device history record was reviewed and confirmed the product was manufactured to specification.There have been no other complaints associated with this lot.Statements from the instructions for use include: "actuate the proximal luer back and forth, visually observing the needle being adequately advanced from the device's distal end.Do not attempt to actuate the injection needle with the catheter in a straightened position." us endoscopy has offered in-service training to the user facility; however, the facility has declined.No additional issues have been reported.
Event or Problem Description
The user facility reported via user facility medwatch # (b)(4) that the carr-locke injection needle did not fully engage during a patient procedure.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: 9225734
• Report Number: 1528319-2019-00039
• Device Sequence Number: 2090641
• Product Code: FCG
• UDI-Device Identifier: 00816765011898
• UDI-Public: (01)00816765011898
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2022
• Device Model Number: 00711811
• Device Catalogue Number: 00711811
• Device Lot Number: 1908748
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1