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

Model Number 00711811

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

Reference user facility medwatch report #5086388.There were no injuries associated with the reported event.

• Brand Name: CARR-LOCKE INJECTION NEEDLE
• Type of Device: INJECTION NEEDLE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, OH 44060 ; 4403586251
• MDR Report Key: 8778442
• MDR Text Key: 150688765
• Report Number: 1528319-2019-00026
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00816765011898
• UDI-Public: (01)00816765011898
• Combination Product (y/n): N
• PMA/PMN Number: K971842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1