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

Model Number	00711811
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The handle on the carr-locke injection needle includes a connector for syringe attachment and a locking mechanism for needle extension.The user facility stated the injection needle did not malfunction but rather, the facility personnel failed to unlock the extended needle after disconnecting the syringe.The devices subject of the reported events were not retained by the user facility for evaluation.The user facility was unable to provide the lot number(s) of the devices subject of this event.A three year review of complaint history finds no similar of reports of needle stick injury during use of the carr-locke injection needle.The instructions for use include the following statements: "when handling the injection needle, always be aware of the distal tip of the needle, and visually confirm that the needle is fully retracted into the device.To unlock the needle, slowly twist the proximal luer counterclockwise until the two luers disengage.When removing the injection needle from the endoscope, fully retract the needle into the sheath to protect the patient and clinician from injury, and to protect the endoscope from potential damage." a us endoscopy representative has provided in-service training to the facility, including instruction on unlocking the needle and verifying needle retraction prior to removing the device from the endoscope.No additional issues have been reported.
Event or Problem Description
The user facility reported user needle stick injuries following use of the carr-locke injection needle, estimated to have occurred three times in the past year.The facility protocol for needle stick injury, which includes patient and user blood sampling, was followed and it was determined no further treatment was needed.

• 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: 8909862
• Report Number: 1528319-2019-00031
• Device Sequence Number: 11238851
• Product Code: FCG
• UDI-Device Identifier: 00816765011898
• UDI-Public: (01)00816765011898
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K971842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1