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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL 3CC DISPOSABLE LUER LOCK SYRINGE W NEEDLE 22GX3/4" DISPOSABLE SYRINGE

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EXELINT INTERNATIONAL, CO. EXEL 3CC DISPOSABLE LUER LOCK SYRINGE W NEEDLE 22GX3/4" DISPOSABLE SYRINGE Back to Search Results
Model Number 26115
Device Problem Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 08/18/2017
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing test record indicated that needle cannula was tested for bending and breakage resistance and all test results are in compliance with iso 9626. The investigation continued on affected sample when received. A visual inspection of the complaint sample identified that part of the needle cannula remained inside the needle hub, indicating material, not bond failure. The surface of the broken needle cannula was not flat/smooth, suggesting that the breakage was caused by a single strong external force beyond the design specifications for this gauge stainless steel needle. The investigation indicates that the breakage of the needle was caused by a strong external bending force that exceeded the design specifications of this gauge needle stainless steel needle and was not due to a product defect.
 
Event Description
The dog (canine, siberian husky mix)) was injected subcutaneously while restrained by a veterinary technician. During the injection, the needle broke off the hub and became lodged under the skin. The attending dvm placed the dog under general anesthesia and surgically removed the needle.
 
Manufacturer Narrative
Device is for human use and not labeled for veterinary use. It is unknown whether the use on animals may result in stresses or conditions that are exceed those that would be expected during use on humans. This is exelint international's first electronic report and it is delayed due to the sign up process for the web trader account.
 
Event Description
The dog (canine, (b)(6))) was injected subcutaneously while restrained by a veterinary technician. During the injection, the needle broke off the hub and became lodged under the skin. The attending dvm placed the dog under general anesthesia and surgically removed the needle.
 
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Brand NameEXEL 3CC DISPOSABLE LUER LOCK SYRINGE W NEEDLE 22GX3/4"
Type of DeviceDISPOSABLE SYRINGE
Manufacturer (Section D)
EXELINT INTERNATIONAL, CO.
2500 santa fe avenue
redondo beach CA 90278
Manufacturer (Section G)
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD
no.758, 5th binhai road
binhai industrial park longwan
wenzhou, zhejiang 32502 5
CH 325025
Manufacturer Contact
navid hamid
2500 santa fe avenue
redondo beach, CA 90278
3106490707
MDR Report Key7054363
MDR Text Key257898921
Report Number1035907-2017-00001
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K861153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2017
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/02/2021
Device Model Number26115
Device Lot Number160802
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2016
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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