MAUDE Adverse Event Report: EXELINT International, Co. EXEL HYPO NDL 27GX1-1/2"; Hypodermic Needle

Catalog Number	26426
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Event or Problem Description
After performing a procedure, the customer reported that he pricked his thumb when he tried to re-cap the needle.
Additional Manufacturer Narrative
The following activities have been performed as part of the complaint investigation regarding the issue with product#: 26426, lot#: 241005.An incoming inspection was performed in accordance with sop-11 incoming inspection procedure for product#: 26426, lot#: 241005.The lot met the established product release criteria, and no abnormalities were observed.The cmo's inspection test records and certificates were reviewed.All required tests met the acceptance criteria in accordance with the iso 7864-2016 and the cmo's product release specification.A review of the complaint details determined that the customer reported pricking his thumb while attempting to recap the needle after completing the procedure.A review of the product manufacturing records confirmed that the product was distributed with the "use once, replace needle protector and discard in accordance with osha, cdc/and or facility safety standards.Label on the packaging did not specifically state, "do not replace the needle cover after use." however, it instructed users to dispose of used needles in accordance with applicable osha for sharps disposal, which advises against recapping used needle where no alternative is available due to the risk of needlestick injury in osha bllodborne pathogens standard, 29 cfr1910.1030(d)(2)(vi).The event occurred after the completion of the procedure when the end user attempted to replace the needle protector onto the needle.A possible contributing factor was the absence of a clear warning explicitly stating against recapping of needles.As a risk reduction measure, the product's instructions for use (ifu) have been updated and included "do not attempt to recap the needle after use.Dispose in an approved sharps disposal container." in ifu-3 instructions for use - exel hypodermic needles ver.6.0, and the product label will be revised in lbl-105 master label for hypodermic needles ver.2.0.(b)(4).

• 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 ; +1(310)649-0707
• MDR Report Key: 50063838
• Report Number: 1035907-2026-00058
• Device Sequence Number: 10705479
• Product Code: FMI
• UDI-Device Identifier: 00020221264265
• UDI-Public: (01)00020221264265(17)290905(30)1(10)241005
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K251089
• Number of Events Summarized: 1
• Summary Report (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): 07/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 26426
• Device Lot Number: 241005
• 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: 07/10/2026
• Initial Report FDA Received Date: 07/28/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown