MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL HYPODERMIC NEEDLE, 27GX1-1/4" T.W.

Catalog Number	26427
Medical Device Problem Codes	Material Integrity Problem (2978); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the needles are leaving a gray/silver metallic residue mark on tissue paper and other media.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
We conducted an investigation on product #26427, lot # 231101 that included the following: production process review: the batch records and the finished product release inspection for this batch were reviewed.There were no changes in raw materials and production processes found.All documentations met the requirements for product release, and no abnormalities or nonconformities are observed.Retained samples testing: a total of five samples were subjected for visual inspection.All samples passed the inspection, and the needles surface were found to be clean and free of foreign materials.A routine testing of black residue detection method or needle cleanliness test was performed.The needles were wrapped with a lint free cloth and placed between two rubber sheets while being rotated and were pulled under a pressure of 20n.No black marks were observed on the lint-free cloths.Based on prior investigations of similar observations, when needles are wiped with white tissue, the transfer of silicone oil from the needle can leave a gray mark on a white tissue.We have conducted a similar test previously by selecting a random batch that left a black or gray mark on the tissue after repeated wiping.This was sent to a third-party testing institution to identify the substance.The test confirmed the residue as siloxane.We noted that the silicone oil is used in needle tubing, and through repeated wiping can deposit or transfer the material on the white tissue paper, altering light reflection and scattering, which can produce slight gray or black appearance.Additionally, incoming inspection has been performed in accordance with sop-11 incoming inspection procedure on product # 26427, lot #231101.The batch passed the criteria for product release with no nonconformities noted.During the investigation, no evidence of manufacturing issues or product release for lot # 231101 has been identified.Based on similar issue and prior residue characterization, the marks observed by the customer appears to be consistent with siloxane or silicone oil that can be transferred on white tissue by repeated wiping and does not indicate a contamination on the needle itself.(b)(4).
Event or Problem Description
Customer reported the needles are leaving a gray/silver metallic residue on patient's skin.However, after further clarification, the customer confirmed that this particular product, product #26427, lot # 231101, did not leave any mark on patient's skin.The issue was associated with a product from another brand.Following this incident, the clinicians began testing several needles, including product # 26427, lot #231101, by wiping them with white tissue papers, which left a gray mark on the tissue.There was no adverse event to the patient.

• Brand Name: EXEL HYPODERMIC NEEDLE, 27GX1-1/4" T.W.
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): EXELINT INTERNATIONAL, CO.; 2500 santa fe avenue; redondo beach 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: 24553800
• Report Number: 1035907-2026-00043
• Device Sequence Number: 12995054
• Product Code: FMI
• UDI-Device Identifier: 00020221264272
• UDI-Public: (01)00020221264272(17)281001(30)1(10)231101
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K251089
• 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): 04/07/2026

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
• Device Catalogue Number: 26427
• Device Lot Number: 231101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown