MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL 1ML SYRINGE 25GX5/8" L-S; Syringe, piston

Catalog Number	26044
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported seven needles popping off the syringe while administrating medication.This was observed at least 36 times.There was no injury or adverse even reported.
Additional Manufacturer Narrative
The cmo conducted an investigation of the reported issue on product#: 26044, lot#: 240903 and the findings are summarized below: retention samples inspection- one hundred retained samples were individually examined.No abnormalities were observed.Retention samples testing- five retained samples were randomly selected and tested.The samples were unpacked, and the connection between the injection needle and the needle hub was inspected.No needle detachment was observed.Additionally, through careful observation of the separated needle of the retained product, all needle hubs and the syringe cone heads were found to be intact and tightly fitted.The connections appeared to be normal, with no signs of needle detachment or looseness.Production process review: the batch record, factory inspection, reports and finished product documentation were reviewed.All documentations were found to be adequate compliant for product release.No non conformities were identified.The complainant refused to provide additional information or documentary evidence such as photos or video.The defective devices in were not returned for evaluation.The incoming inspection has been conducted on product#: 26044, lot#: 240903 at exelint in accordance with sop-11 incoming inspection procedure.This batch passed the inspection with no related nonconformities noted.All retained samples were tested, production process documentation was reviewed, and the incoming inspection was evaluated.All findings met the product release criteria, and no nonconformities were identified.Based on available information, we were not able to determine a root cause or replicate the reported issue during our investigation.(b)(4).

• Brand Name: EXEL 1ML SYRINGE 25GX5/8" L-S
• Common Device Name: Syringe, piston
• 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: 22862765
• Report Number: 1035907-2025-00034
• Device Sequence Number: 7685830
• Product Code: FMF
• UDI-Device Identifier: 00020221260441
• UDI-Public: (01)00020221260441(17)290803(30)1(10)240903
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

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: 26044
• Device Lot Number: 240903
• 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: 08/04/2025
• Initial Report FDA Received Date: 08/21/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown