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 Type  malfunction  

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 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
• 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: 9225734
• MDR Text Key: 170082822
• Report Number: 1528319-2019-00039
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2019
• 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