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

Model Number	00711811
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a review of the maude database, us endoscopy became aware of user facility medwatch #mw5086388 which reported fluids including saline solution could not be passed through the carr-locke injection needle (00711811).It is not clear from the record what other fluids were attempted nor in what order.The maude record did not identify the name or location of the user facility, and no product has been returned to us endoscopy for evaluation.A review of us endoscopy complaint history finds no similar report of failure to pass fluid for the carr-locke injection needle (00711811) in the 12 months prior to the maude report date.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.In-service training could not be offered due to lack of facility information.
Event or Problem Description
Reference user facility medwatch report #5086388.There were no injuries associated with the reported event.

• 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: 8778442
• Report Number: 1528319-2019-00026
• Device Sequence Number: 11257120
• Product Code: FCG
• UDI-Device Identifier: 00816765011898
• UDI-Public: (01)00816765011898
• Combination Product (Y/N): N
• PMA/510(K) Number: K971842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2019

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: 03/19/2022
• Device Model Number: 00711811
• Device Catalogue Number: 00711811
• Device Lot Number: 1903736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1