MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL 3ML SYR ONLY L-L; SYRINGE ONLY

Catalog Number	26200
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There have been no similar complaints within the lot.Further investigation of this issue is still ongoing.(b)(4).
Event or Problem Description
The customer discovered that one syringe contained a dead insect sealed inside the sterile packaging.The sterile sleeve was fully intact and was not opened.The device was not used.
Additional Manufacturer Narrative
As part of the complaint investigation, 100 retained samples from the lot were visually inspected for the presence of any foreign bodies or insects within the blister packaging.Batch production records were reviewed, and no abnormalities were detected in the production process or finished product inspection.The customer returned the impacted product for investigation.Upon inspection, the returned blister was still sealed; however, there was a hole in the blister packaging that appears to have been created by an insect.This hole is the most likely entry point through which the insect gained access to the sealed blister package and can be seen in the initial pictures provided by the customer.Analysis of the insect remains found that its features were highly consistent with those of tribolium castaneum otherwise commonly known as the red flour beetle.The red flour beetle is a worldwide storage pest that mainly infects stored food such as flour and is common in household settings.It should be noted that the customer stated that the syringes were "stored in an acrylic drawer under the sink in [his] bathroom." the origin of the insect involved in this incident, as well as the timing of when it created the hole in the blister packaging is unknown.Manufacturing of this product is done in a class 100,000 cleanroom where product is heat sealed within the blister packaging then immediately transported to the packaging room for final inspection and further packaging within the inner box and case.At the manufacturing site, there is monthly centralized fumigation, and there have been no similar instances of pests found during manufacturing.At exel's warehouse, pest control servicing is performed monthly and there have been no pest issues impacting product or spottings of the red flour beetle.Additionally, there have been no similar complaints within the lot.Therefore, it is unlikely that this insect was introduced during manufacturing or storage at exel.(b)(4).

• Brand Name: EXEL 3ML SYR ONLY L-L
• Common Device Name: SYRINGE ONLY
• Manufacturer (Section D): 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: 24371235
• Report Number: 1035907-2026-00042
• Device Sequence Number: 5018242
• Product Code: FMF
• UDI-Device Identifier: 00020221262001
• UDI-Public: (01)00020221262001(17)290824(30)1(10)240924
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Other
• 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
• Device Catalogue Number: 26200
• Device Lot Number: 240924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 40 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White