MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL HYPO NDL 23GX3/4"; HYPODERMIC NEEDLE

Catalog Number	26407
Medical Device Problem Codes	Contamination (1120); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Retained sample inspection: 100 pieces of retained samples of hypodermic needles from product # 26407, lot # 240401 were retrieved for visual inspection.All components were clean and free of foreign objects.Production process review production records associated with product # 26407, lot # 240401 were reviewed.All documents met the requirements for product release standards.No abnormalities or nonconformities was noted.(b)(4).
Event or Problem Description
Caller reported needle contamination.Black particles were found on the needle hub on a brand-new needle., product # 26407, lot # 240401.No adverse event reported as the contamination was noted right away.
Event or Problem Description
Caller reported needle contamination.Black particles were found on the needle hub on a brand-new needle., product # 26407, lot # 240401.No adverse event reported as the contamination was noted right away.
Additional Manufacturer Narrative
Cmo conducted an investigation on product # 26407, lot #240401.The investigation included the following.-production process investigationproduction records for product # 26407, lot # 240401 were reviewed.No changes to raw materials or the production process were identified for this lot.The products were assembled by machine, and no abnormalities were noted during production.All documentation meets the requirements for product release.No nonconformances or abnormalities associated with the manufacturing of this batch were identified.-retained samples testingone hundred pieces of retained samples from product # 26407, lot # 240401 were subjected to visual inspection.All samples were found to be clean and free of foreign materials and were compliant with the iso 7864:2016 requirements.-incoming inspection has been performed in-house by following sop-11 incoming inspection procedure.The batch passed all inspection criteria for product release.No nonconformances related to the lot was noted.-product in question with the foreign material was not returned for evaluation.Therefore, material identification of the quality issue could not be performed as part of this investigation.A review of the relevant manufacturing process documentation and the visual inspection did not reveal any nonconformities.No abnormalities or nonconformities were identified during the manufacturing or retained samples testing.The photos provided by the end user were reviewed as part of the investigation.Based on the visual assessment, the reported foreign material appears to resemble charred particulates that may potentially be generated during the injection molding process.However, the defective product with the foreign particulates was not returned for evaluation.Therefore, the foreign materials in the product could not be confirmed or identified.As a result, the root cause remains unconfirmed.Based on available information and the results of the investigation, this complaint will be closed.Although a confirmed root cause was not identified, preventive measures were implemented.On 11/17/2025, a routine training was conducted on all relevant hypodermic needle workshop personnel on the following procedures.- inspection regulations for disposable hypodermic needles (machine assembled for standard and needle stick prevention types) and - process hygiene management system.The training occurred after the manufacture of product # 26407, lot # 240401 and therefore did not impact the investigated lot.The training was conducted as a preventive measure to reinforce adherence to existing inspection and hygiene requirements to reduce the potential risk of foreign particulate contamination.Additional investigation and review activities was requested, including review of -current equipment calibration - process monitoring controls -line clearance procedures.These reviews were conducted to verify continued manufacturing compliance and to help prevent recurrence of the reported issue.No similar issues were identified with this lot.(b)(4).

• Brand Name: EXEL HYPO NDL 23GX3/4"
• 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: 24282856
• Report Number: 1035907-2026-00041
• Device Sequence Number: 13243510
• Product Code: FMF
• UDI-Device Identifier: 00020221264173
• UDI-Public: (01)00020221264173(17)290129(30)1(10)240401
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 26407
• Device Lot Number: 240401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/05/2026
• 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
• Patient Sex: Unknown