MAUDE Adverse Event Report: US ENDOSCOPY; INJECTION NEEDLE

Model Number	00711812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via vigilance report that during a patient procedure the connector to their carr-locke injection needle was broken.The procedure was completed successfully using a different needle.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event is being returned to steris for evaluation.Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Additional Manufacturer Narrative
The device subject of the reported event was returned to steris for evaluation.Upon evaluation, it was discovered that the top portion of the leur had detached from the leur stem, however an exact cause of the detachment could not be determined.The carr-locke injection needle ifu 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 device history record for the lot subject of the event was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.A complaint review confirmed this to be an isolated event for the subject lot.No additional issues have been reported.

• Brand Name: NA
• Common Device Name: 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 ; 4403586251
• MDR Report Key: 23647302
• Report Number: 1528319-2025-00108
• Device Sequence Number: 4823276
• Product Code: FCG
• UDI-Device Identifier: 00724995180898
• UDI-Public: (01)00724995180898(11)250722(17)280722(10)12637949
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K232826
• 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): 11/25/2025

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)12637949
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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