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U.S. Department of Health and Human Services

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

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UNITED STATES ENDOSCOPY GROUP, INC. CARR-LOCKE INJECTION NEEDLE Back to Search Results
Model Number 00711811
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Needle Stick/Puncture (2462)
Event Type  malfunction  
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 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.
 
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Brand NameCARR-LOCKE INJECTION NEEDLE
Type of DeviceINJECTION 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 Key8909862
MDR Text Key155184917
Report Number1528319-2019-00031
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 08/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number00711811
Device Catalogue Number00711811
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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