MAUDE Adverse Event Report: US ENDOSCOPY CARR-LOCKE INJECTION NEEDLE

Model Number	00711812
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch (b)(4) that their carr-locke injection needle was leaking during a patient procedure.No report of injury or procedure delay.
Additional Manufacturer Narrative
The carr-locke injection needle subject of the reported event is being returned for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The carr-locke injection needle subject of the reported event was returned for evaluation.Examination revealed that the needle was both clogged and corroded with rust.Further review of the device found a gap in the glue bond, which was identified as the cause of the reported leaking of the device.The cause of the gap could not be determined.The carr-locke injection needle instructions for use states, "carefully remove the tip protector from the distal tip of the needle.Actuate the proximal luer back and forth, visually observing the needle being adequately advanced from the device's distal end.The spring-loaded handle assists in needle retraction; however, always visually check the retraction as well.Note: do not stretch the device because stretching may cause the needle projection length to be altered.Do not attempt to actuate the injection needle with the catheter in a straightened position.The injection needle has been engineered and manufactured with a specific "preload" that is necessary to assure the full projection and full retraction of the needle from the distal hub when the device is in very tortuous configurations.Using accepted medical methods, purge the needle assembly of air using 0.5-0.75cc of injection media." steris offered in-service training on the proper use and operation of the carr-locke injection needle; however, the user facility declined.The device history record for the subject lot was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.A complaint review was performed and confirmed the event to be isolated for the subject lot.No additional issues have been reported.

• Brand Name: CARR-LOCKE INJECTION NEEDLE
• Common Device Name: CARR-LOCKE INJECTION NEEDLE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4405197842
• MDR Report Key: 22818725
• Report Number: 1528319-2025-00086
• Device Sequence Number: 17571173
• Product Code: FBK
• UDI-Device Identifier: 00724995180898
• UDI-Public: (01)00724995180898(11)250421(17)280421(10)12339956
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K971842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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 Model Number: 00711812
• Device Catalogue Number: 00711812
• Device Lot Number: (10)12339956
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown