MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. CARR-LOCKE INJECTION NEEDLE

Model Number	00711811
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris became aware of this event on august 5, 2020 through our periodic review of the maude database.To-date we have not been informed of this event directly from the user facility.Investigation of this event is in process.A follow-up report will be filed detailing the investigation.
Event or Problem Description
Through review of the maude database, steris endoscopy discovered user facility medwatch report number mw5095362, which reported that a carr-locke injection needle would not open / failed to function.
Additional Manufacturer Narrative
The carr-locke needle subject of the reported event has been received by steris endoscopy.Evaluation of the returned device found the device to be functional; the reported failure to deploy could not be duplicated.
Additional Manufacturer Narrative
Upon follow up with the user facility, steris endoscopy has confirmed that there was no harm to the patient.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.Steris endoscopy has not received the device subject of this event for evaluation.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." steris endoscopy has offered in-service training on the use of the carr-locke injection needle; however, the user facility has declined.

• 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: 10376295
• Report Number: 1528319-2020-00025
• Device Sequence Number: 19504794
• Product Code: FCG
• UDI-Device Identifier: 00724995180881
• UDI-Public: (01)00724995180881
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020

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: 02/03/2023
• Device Model Number: 00711811
• Device Catalogue Number: 00711811
• Device Lot Number: 2001301
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 08/05/2020; 08/05/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/05/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1