MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL HYPO NDL 27GX1-1/2; HYPODERMIC NEEDLE

Catalog Number	26426
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).- production records for product # 26426, lot # 231101 were reviewed, there were no abonormalities found identified during the manufacturing process.- a totla of twenty retained samples were randomly selected for analysis and testing.These samples were tested for visual appearance inspection, rigidity, toughness, and firmness detection.Al tested samples met the specified test requirements, with no defects or quality issues observed.-at the time of this report, the defective device has not been returned by the complainant for further analysis.
Event or Problem Description
A complainant reported needle quality issue; the needle broke off behind kneecap.A scalpel had to be used to open the patients kneecap to remove the needle.Prior to the knee injection procedure, they aspirated 27 cc of serous fluid.At the end of the aspiration, they noticed that the needle had dislodged deep in the retropatellar space.Surgical retrieval of the broken off needle was required, as the entire metallic needle was in the deep retropatellar space.The complainant stated that they were able to retrieve the broken off and dislodged needle in its entirety via a hemostat, with the aid of fluoroscopy and surgical dissection.
Additional Manufacturer Narrative
(b)(4).An investigation on product # 26426, lot # 231101 has been performed and the results are as follows: production process review: the production records were reviewed, and no abnormalities were found in the production process.The raw materials and production techniques remained unchanged.Retained samples testing or batch sample inspection: a total of twenty pieces of retained samples were inspected for appearance.All needle tubes and hubs were fully bonded with adhesives, and no abnormalities were observed.Ten samples were tested for rigidity and toughness according to the iso 7864:2016.Standard.All samples tested passed without any fractures observed.The remaining ten samples were subjected to firmness test according to iso 7864:2016.A 22n pulling force was applied, no detachment occurred between the hubs and the needle tubes, and no needle fractures were detected.Furthermore, an additional analysis has been performed on the information and photo provided by the complainant.The reported measurement length of the needle was 3.8 cm, which was bent at the 2.9cm position or mark, indicating significant bent or deformation of the needle.The intended use of the injection needle is for injecting and extracting liquids from the human body.During clinical use, especially in hard positions or hard to access areas such as the retropatellar joint space, there is a risk of needle breakage or damage.If the needle tube becomes stuck and an excessive force is applied, the bending angle may exceed 20 degree limit, increasing the risk of bending or breaking of the needle tube.Defective device was not returned for further investigation.Based on the result of the investigation conducted, all retained samples tested passed the inspections and test requirements for product release, with no non conformances or quality defects detected.A potential root cause may be excessive bending of the needle, exceeding the 20 degree deflection limit in hard position or hard access areas like the retropatellar joint space during clinical use.However, this cannot be confirmed due to the limited information and the absence of defective device to examine.Therefore, the root cause remains unconfirmed.
Event or Problem Description
A complainant reported needle quality issue; the needle broke off behind kneecap.A scalpel had to be used to open the patients kneecap to remove the needle.Prior to the knee injection procedure, they aspirated 27 cc of serous fluid.At the end of the aspiration, they noticed that the needle had dislodged deep in the retropatellar space.Surgical retrieval of the broken off needle was required, as the entire metallic needle was in the deep retropatellar space.The complainant stated that they were able to retrieve the broken off and dislodged needle in its entirety via a hemostat, with the aid of fluoroscopy and surgical dissection.The needle measurement l (3.8 cm which was bent at 2.9 cm).

• Brand Name: EXEL HYPO NDL 27GX1-1/2
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): EXELINT INTERNATIONAL, CO.; 2500 santa fe avenue; redondo beach CA 90278
• Manufacturer (Section G): EXELINT INTERNATIONAL, CO.; 2500 santa fe avenue; redondo beach CA 90278
• Manufacturer Contact: vu doan ; 2500 santa fe avenue; redondo beach, CA 90278 ; 3106490707
• MDR Report Key: 22162886
• Report Number: 1035907-2025-00029
• Device Sequence Number: 9408614
• Product Code: FMF
• UDI-Device Identifier: 00020221264265
• UDI-Public: (01)00020221264265(17)281001(30)1(10)231101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K861153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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?: Yes
• Device Catalogue Number: 26426
• Device Lot Number: 231101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male