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

Model Number	26426
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The incoming inspection has been performed on product#: 26426, lot: 231101 in accordance with sop-11, incoming inspection procedure.The lot passed the inspection with no non-conformities reported.The cmo has conducted an investigation that included the following: production process review: the production records of this batch were reviewed, and no abnormalities were found in the production process.The raw materials and production techniques remained unchanged.Batch sample inspection: twenty pieces of samples from batch number: 231101, specification 27g×1-1/2", were tested: 1) each sample was inspected for appearance.All needle tubes and hubs were fully bonded with adhesive, and no abnormalities were observed.2) ten samples were tested for rigidity and toughness according to the iso 7864:2016 standard.All samples passed the test without any fractures observed.3) the remaining ten samples were tested for firmness test in accordance to iso 7864:2016.A 22n pulling force was applied, no detachment occurred between hubs and needle tubes, and no needle tube fractures were detected.All test performed passed the inspection and were deemed qualified.The complainant stated that the defective needle hub was immediately discarded, and therefore won't be available for investigation.The complainant confirmed on (b)(6) 2025, that the needle has been retrieved from the patient, and was advised to provide photos, videos, and measurements of the needle.In summary, all retained samples were found to be qualified for product release with no needle detachment or breakage detected in the tested samples.It is likely that the needle could break if bend beyond the 20 degrees limit or subjected to external force during clinical use; however, this cannot be confirmed.Therefore, the root cause remains unconfirmed due to the lack of defective product to examine.
Event or Problem Description
The caller reported that during neck surgery, the hypodermic needle snapped during the procedure.The doctor attempted to locate the needle during the procedure but could not find it.Three days later, the patient was advised to undergo an x-ray.The x-ray results confirmed the needle had been left in the patient's neck.The doctor stated that the patient did not feel or experience any pain when the issue was initially reported.

• 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: 21721941
• Report Number: 1035907-2025-00028
• Device Sequence Number: 19798773
• Product Code: FMF
• UDI-Device Identifier: 00020221264265
• UDI-Public: (01)00020221264265(17)281001(30)1(10)231101
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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 Model 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: 03/07/2025
• Initial Report FDA Received Date: 03/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female