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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 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.
 
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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 Key8778442
MDR Text Key150688765
Report Number1528319-2019-00026
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00816765011898
UDI-Public(01)00816765011898
Combination Product (y/n)N
PMA/PMN Number
K971842
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/19/2022
Device Model Number00711811
Device Catalogue Number00711811
Device Lot Number1903736
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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