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

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

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.

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.

• Brand Name: EXEL 3CC DISPOSABLE LUER LOCK SYRINGE W NEEDLE 22GX3/4"
• Type of Device: DISPOSABLE 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 Key: 7054363
• MDR Text Key: 93600049
• Report Number: 1035907-2017-00001
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00020221261158
• UDI-Public: 0020221261158
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K861153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/02/2021
• Device Model Number: 26115
• Device Lot Number: 160802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 19 WK
• Patient Weight: 17