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

Model Number	00711811
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch report (b)(4)."this was a failure of equipment, specifically the carr-locke injection needle 25 ga steris brand.When instructed to bring needle out, needle was pushed out and worked properly, but when needle was attempted to be brought back in, the needle stayed out despite luer-lock device being fully disconnected." the procedure was completed successfully with another injector needle.No report of injury.
Additional Manufacturer Narrative
The carr-locke injection needle subject of the reported event is not available for evaluation.Without the r eturn of the device a root cause cannot be determined.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 was reviewed for the subject lot and 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: NA
• 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 ; 4404130648
• MDR Report Key: 21555119
• Report Number: 1528319-2025-00015
• Device Sequence Number: 4402347
• Product Code: FCG
• UDI-Device Identifier: 00724995180881
• UDI-Public: (01)00724995180881(11)241104(17)271101(10)11234149
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 00711811
• Device Catalogue Number: 00711811
• Device Lot Number: (10)11234149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 03/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2024
• 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